Medical devices include various medical equipment (instruments, apparatus, machines, appliances, software, etc.) used for different medical purposes. A medical device plays a critical role in diagnosing, monitoring, preventing, treating, and alleviating diseases. Medical devices can be as simple as simple tongue depressors and complex as pacemakers, closed-loop artificial pancreas systems, etc. In vitro diagnostic (IVD) products (blood glucose meters, test kits, and reagents) are also included in medical devices.
Know anyone building innovative solutions that belong in this 'Medical Devices'?
MD&M West brings together medtech engineers, business leaders, disruptive companies, and innovative thinkers to create powerful solutions and life-changing medical devices. DISCOVER medical design and manufacturing innovations and technology. Discover and demo the latest products, technology, and solutions from more than 1,400 suppliers. Explore the other four engineering trade shows that share the expo floor with MD&M West. From packaging to plastics to robotics, our five-in-one design and manufacturing event connects you across multiple verticals and industries.
Discover thousands of medical products and solutions that are changing the healthcare landscape live and in-person at the Dubai World Trade Centre from 30 January - 2 February 2023 and online from 4 January - 2 March 2023. Long established as the ‘must attend’ event in our region, we attract regional and international healthcare professionals who value the power of learning, networking and business. Bringing together policy drivers, thought leaders, healthcare professionals and decision-makers in order to address healthcare's most pressing challenges through collaboration and empowerment.
World Conference on Pharma Industry and Medical Devices scheduled during December 05-06, 2022 at Zurich Switzerland. The Conference emphasizes the theme “Exploring Innovative Developments in Pharma Industry & Medical devices”. It covers a wide range of important sessions. Pharma Conference 2022 is a two-day program which includes thought inspiring Keynote Presentations, Plenary Talks, Symposiums, Special Sessions and Career Development Programs.
The conference will also witness professionals gathering from Academic, Pharma industry Research and Development wings, API: Active Pharmaceutical Ingredients industry, Drug discovery laboratories, Formulations and NDDS domains. Also executives and eminent research personalities from the departments pharma Chemistry: Quality control and Quality assurance, Clinical trials and Pharma covigilance, Pharmaceutical Manufacturing, Pharamacognosy, Bio pharmaceutics, Drug Discovery, Design & Development and Pharma economics shall be an integral part of this conference.
18th Annual Pharmaceutical and Medical Device Compliance Congress. November 6th-8th at the Mandarin Oriental in Washington DC. The Pharma & Medical Device Congress is now offering a limited number of partial and full Tuition Scholarships to qualifying representatives of government, consumer advocate organizations, academics, students, representatives of health services research organizations, and those who have lost their jobs as a result of the COVID-19 pandemic.
The 27th Annual Phoenix Conference will bring together top-level executives from large healthcare companies and CEOs of small, venture-backed firms for an opportunity to discuss critical issues of interest to the medical device industry today, as well as to network and gain valuable insights from both industry leaders and peers. This exclusive, two-day in-person event will provide an unrivaled experience that will help inform and shape company strategy for the years ahead. We are excited to bring our community back together in 2022. To ensure the health, safety, and comfort of our attendees, the organizers require proof of vaccination to attend the Phoenix Conference 2022.
DeviceTalks is a conversation among leaders, an evening for an exchange of ideas, insight and contacts among the pioneers of the medical technology industry. Join us on October 19-20 at the Santa Clara Convention Center to better understand how medical device manufactures, suppliers and innovators are finding success in a challenging economic market.
Optimize your regulatory oversight with perspectives from notified bodies and industry peers. Speakers exchange practical methods to strengthen regulatory strategy, best practices for communicating with notified bodies and lessons learned in receiving approval with limited guidance. Improve patient outcomes and internal operations by gaining methods to achieve sufficient data for successful product submissions.
Setting the standard on how the industry should connect and exchange ideas, the American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, product development, innovation, technology and quality/ regulatory aspects of medical devices. Join the discussion with over 250 of your industry peers as we explore the challenges and opportunities in medical device innovation, regulatory harmonization, compliance, digital transformation and more. Hear first-hand case studies presented by our executive speaker faculty with extensive experience driving development and process strategy excellence. Walk away with strategic insights for industry, hospital networks and regulatory bodies to collaborate together to streamline processes, optimize development, design, decrease risk, improve speed to market, reduce costs and remain compliant in a rapidly evolving landscape. This October, we encourage you to join us for two days of thought provoking content and exceptional networking.
Recognize the impact of public policy on the medical device industry in terms of global market expansion and competitiveness
Leverage innovation to accelerate speed to market while reducing risk
Utilize your post-market surveillance system to feed your risk management and product lifecycles
Identify the opportunities and challenges in various regulatory markets, alongside an analysis on potential modifications to 510k policy
Create a successful partnership with suppliers and contract manufacturers
Reduce up-front investment and market risk through effective and frequent prototyping early in the development cycle
Incorporate performance, safety, business economics, risk management, and regulatory requirements as a basis for device design
Apply ‘Design Thinking’ as a driver for medical device development
Ensure the design of the medical device can be correctly translated into production specifications
Understand the impact EU MDR and increased harmonization in the medical device Industry
Preparing for the next generation of medical devices and embracing value-based health care
Develop and sustain the gains of a quality culture and adopt proven change management techniques
The 4th Annual European Medical Device and Diagnostic Post-Market Proactive Surveillance and Vigilance Conference is an interactive knowledge-sharing platform that will provide strategies for developing a robust post-market vigilance combined with a well-integrated proactive plan to enhance PMS and Vigilance processes. Early implementation of proactive measures will help satisfy regulatory requirements, achieve a competitive edge, and reduce the tangible costs of downstream field corrective actions. Delving into the EU MDR & IVDR – this two-day conference will unearth some of the best strategies for streamlining complaint intake operations, adverse event detection, handling FSCA, managing off-label device use & complaints linked to IFUs, PMCF activities, leveraging patient surveys, creating compliant PSURs, trend reporting, benefit-risk assessment, creating a feedback loop for product improvement and much more.
The two-day Conference features presentations by leading international medical device experts with thought-provoking guest speakers, all providing an insight on cutting-edge topics for medical device manufacturers, R & D and design engineers in the rapidly evolving Irish and global device market place. Medical Technology Ireland will bring together manufacturers, clinicians, academic institutions, entrepreneurs/start-ups, financial institutions and suppliers alike in a combined programme, defining present and future medical device trends, to investigate, discuss, and improve the quality of life and to increase the life expectancy for patients worldwide.
Discover unmet user needs in sessions with regulatory authorities and medical device peers. Speakers will share evolving FDA requirements and practical and effective testing roadmaps to ensure needs are translated into design concepts. Take away innovative perspectives that meet requirements and deliver product safety. Foster a sense of collaboration and safely connect with peers and expert presenters at this intimately-sized program. Customize your experience and address your unique concerns during dynamic Q&A after each session. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session types allow you to stay engaged.
The bureau has new recommendations for healthcare organizations to address unpatched medical devices, which it says are increasingly being targeted in cyberattacks.
On Tuesday, the FBI issued a report …
It’s no secret that the future of the Healthcare Industry lies in technology. Medical Devices have the potential to revolutionise medical treatments, diagnostics, patient engagement and quality of life. Yet, innovation comes with ever increasing regulatory scrutiny and security challenges. The 10th Annual Software Design for Medical Devices Global Forum is the ONLY conference that is dedicated to ensuring your teams can achieve regulatory compliance and protect your devices from increasing cyber threats, whilst still embracing the cutting edge designs to get to market faster and stand out from your competitors.
Ensure you can meet future medical needs by adopting innovative software design methodologies
Understand the implication of the new MDR and IVDR implementation and ensure that you're fully compliant
Ensure your cybersecurity is airtight to protect your devices and evaluate how you can safely implement AI without compromising on security
Enhance your product quality and gather intelligence on tech companies' perspective on SDMD
Take away key strategies to industrialise your software development to take your device to market quicker and more efficiently
Over the past decade, medical device manufacturers, patients, health systems and other stakeholders have seen a shift in the way devices are being purchased, paid for and reimbursed, all to support the value-based care movement. As health systems look to integrate delivery networks and group purchasing organizations to ensure comprehensive pricing models, manufacturers must consider the impact a product will have on a longer care cycle for patients. With the added shift of the pandemic, other considerations surrounding virtual contracting etiquette, the rise of outpatient centers, and creative avenues to abide by compliance standards are at front of mind. Foster a sense of collaboration and safely connect with peers and expert presenters at this intimately-sized program. Customize your experience and address your unique concerns during dynamic Q&A after each session. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session types allow you to stay engaged.
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Finding your way through the regulations, standards, and interpretations applicable to health software – particularly software as a medical device (SaMD) – can be daunting. In this two-day, in-person workshop, regulatory experts will explore the current and evolving global regulatory requirements affecting SaMD, how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under global requirements. Attendees will learn how to address the numerous challenges in performing risk management/assessment for software by completing required evaluations using practical case studies. Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. Since performing risk management/assessment for software is generally more challenging, attendees will work through completing required evaluations using practical case studies.
The world is working on bouncing back at a normal life after a destructive pandemic, and humanity’s collective awareness of the importance of the healthcare sector has consequently climbed up. Be it a simple nebulizer or an advanced robotic surgical system, each medical device needs to be produced with the highest level of attention and innovation in order to address the overarching needs of today’s medical world. Therefore, developing modern, technologically advanced, and low-risk medical devices is more important than it has ever been for the healthcare sector.
A single medical device can be life-changing for a patient when it is used correctly and as long as it operates successfully; yet achieving this comes with many challenges. It is vital for healthcare institutions to ensure the effectiveness and safety of operating medical devices to avoid pitfalls. In order to achieve this, building a strong and meaningful network between medical leaders around the world is necessary to secure a flow of knowledge and experiences that serve the well-being of human life.
Medical Device Safety and Regulation Compliance Forum by GlobalBSG creates a collaborative platform for executives involved in the regulation, design, product safety, development, innovation, technology, monitoring, and quality aspects of medical devices. Industry professionals will exchange field knowledge and useful practices in producing high-quality medical devices and keeping the safety level at the highest level through advanced risk management strategies.
A critical part of the benchmark development work will involve analysis of findings from a self-assessment cybersecurity maturity survey that medical device vendors are invited to take online. But an …
For over 25 years the Kazakhstan International Healthcare Exhibition - KIHE - is the largest demonstration platform of achievements in the field of scientific and practical medicine and pharmaceuticals in Central Asia. KIHE annually brings together doctors of various specialties, pharmacists, government officials and business persons from different countries. Annually the manufacturers and suppliers of medical equipment, devices, consumables for clinics and laboratories; medical products for various purposes; equipment for the production, packaging and labeling of pharmaceuticals take part in KIHE. International forums, conferences, round tables and master classes with the participation of representatives of government agencies, businesspersons, heads of the medical institutions and pharmaceutical companies are being held within the exhibition. KIHE is officially supported by the Ministry of Health of the Republic of Kazakhstan, Almaty Akimat, Almaty State Public Health Administration, the National Medical Association and the Eurasian Medical Association.
In the medical device industry, there is a growing conflict between the fast-paced technology world and slow-paced regulatory world this is a challenge that must be addressed to maintain a competitive advantage. This May, the Medical Device Software Development Summit returns- for the first time in person! Join leading device manufacturers in Boston as they come together to address and overcome obstacles ensuring you can design and develop software that is innovative, compliant, and secure.
Compliant Integration of Third-party Computing Technologies lead by Pat Baird, Head of Regulatory & Global Software Standards, Philips and Randy Horton Co-Chair, AAMI
Journey & Learnings from Waterfall to Agile in Medical Device Software Development lead by Vaibhav Agarwal, QA Manager, GE Healthcare, and Karl-Heinz Fleischer, Senior Agile Transformer, GE Healthcare
Cybersecurity for Connected Devices lead by Arnab Ray, Director, Product Cybersecurity Abbott
On behalf of the Scientific Program Planning Committee and PDA, we are proud to present the second edition of the 2022 PDA Medical Devices and Connected Health Conference and warmly welcome you to Dublin/Ireland. Connected Health solutions involving data platforms, connectivity, software, and sensors for health have the potential to ensure better individual patient care through the provision of more effective treatments, while at the same time reducing efforts for healthcare professionals to improve efficiency in healthcare systems. Effective and efficient means that digital health is also confronted with the variety and complexity of the medical device and pharmaceutical regulatory scheme, the insurance/reimbursement setup as well as the management of data security and information misuse. Although success has been demonstrated in many areas, there are also challenges in showing effectiveness, especially at scale in real-world situations with the evidence that meets stringent demands of the various healthcare stakeholders and which also aligns cost with benefit.
What kinds of opportunities and threats are associated with digital healthcare from the industry as well as from the regulators’ point of view? Which experiences and learnings are emerging from previous work and particularly from the recent pandemic situation? And finally – which options exist for digital solutions to leave a positive impact on healthcare, while reducing its environmental footprint?
We are convinced that an open dialogue and experience exchange between all parties involved is the most appropriate way to “unleash the power” of medical devices and connected health. We have received excellent speaker abstracts and believe that we have put together an engaging conference program that focuses on these issues and will provide an ideal environment for an interactive discussion around the opportunities and challenges offered by connected health solutions.
This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. Reserve your spot for the FDA/AdvaMed Medical Device Statistics Issues Conference this May. In an effort to provide quality programming in the safest and most effective manner possible, the Conference will be held virtually once again. This is our seventh year holding the Poster Session at the FDA/AdvaMed Statistics Conference.
International Conference on Biomedical Devices and Healthcare Informatics aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of Biomedical Devices and Healthcare Informatics. It also provides a premier interdisciplinary platform for researchers, practitioners and educators to present and discuss the most recent innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the fields of Biomedical Devices and Healthcare Informatics.
For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation, the premier event for medical device experts become up-to-date on the latest development, changes, and trends in health technology standards and regulations. In April, the global medical device standards community will come together in-person for the first time since 2019 for a dynamic and practical review of recent changes to the regulatory landscape and the lessons learned from the pandemic impacts on the global medical device marketplace.
On behalf of International Medical Devices Expo, we are delighted to welcome you to join the Congress scheduled on April 20-21, 2022 at Berlin, Germany. Which is an exceptional gathering where the worldwide prominent scientists, Directors, Professors, exhibitors, Postdocs, Researchers, Academic Staff are about to share their research work and acquiesce new emerging technological trends in the field in the conference areas. MEDICAL DEVICES 2022 is an International platform to adverse and study about the latest technology, innovations, applications, and intense research to Share complete Knowledge. The conference contains significant international experts, professor, specialists, research scholars and Student Delegates and Exhibitors. Conference will be featuring oral presentations, poster presentations, keynote talks, workshops, Expo of Medical devices and many more. The conference will focus on various kinds of devices that are used in field of medical common medical devices, Cardiac Devices, Paediatric medical devices, Orthopaedic & Orthotic Devices, Surgical Medical Devices Perspectives on Physical Medicine and Hospital Equipment Business and Market.
The 6th Annual Medical Device Cybersecurity Risk Mitigation Conference will bring together cybersecurity experts from medical device manufacturers and health delivery organizations to share best practices on how to ensure patient safety is protected. This premier virtual event provides programming focused on addressing issues of shared responsibility, best practices for securing devices and data, and takes a dive deep into the complexity of maintaining products in the field all while ensuring compliance with new guidance.
Cybersecurity attacks in healthcare have been on the rise in recent years. With medical devices ranging from legacy devices to mobile phone apps, cybersecurity risk mitigation must take top priority as MDOs and HDOs strive to maintain device security, protect patient data, and also comply with FDA and EU guidance. As the effects of new guidance and government initiatives reshape the landscape of development, production, and application, manufacturers and HDOs must work towards building a new culture of shared responsibility, uniformity, and harmonization.
Panel discussions will offer industry insights from leading professionals, and national & global legal perspectives. Industry experts will discuss strategies for optimizing medical device security with enhanced risk management oversight and also explore cybersecurity threat testing to ensure alignment and compliance with global requirements. This event will also include case studies with industry thought leaders on product security and patient safety, including robust risk assessment and a holistic approach to lifecycle management of devices. This is a two-day program with multiple breaks to maximize retention and engagement. Q1 Production’s advanced event platform offers the ultimate virtual experience. Thoughtfully designed, customizable, networking features foster a sense of collaboration, discussion, allowing attendees to make direct connections.
MD&M West brings together medtech engineers, business leaders, disruptive companies, and innovative thinkers to create powerful solutions and life-changing medical devices. Explore the other four engineering trade shows that share the expo floor with MD&M West. From packaging to plastics to robotics, our five-in-one design and manufacturing event connects you across multiple verticals and industries. Discover and demo the latest products, technology, and solutions from more than 1,400 suppliers.
At MD&M West, suppliers have the ability to meet serious buyers in-person and grow their business with the right customers.
The University of Minnesota's Earl E. Bakken Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering and the Department of Mechanical Engineering presents the 21st Annual Design of Medical Devices Conference, April 11-14, 2022.
Provide a national forum to bring together world-class medical device designers, researchers, manufacturers, and the public sector to share perspectives and innovations in medical device design,
Showcase the University of Minnesota as a leader in the medical device community, and
Raise funds from corporate sponsorships to support medical device education at the University of Minnesota
Medical device manufacturers with robust human factors processes are leading the market, proving to have better clinical outcomes and better quality. Attend AAMI’s three-day Human Factors for Medical Devices training to understand critical human factors processes to consider when designing a medical device, how they affect its safety, and which steps to take to mitigate risks. Hear directly from FDA representatives from CDRH and CDER about the expectations for device usability, how best to conduct human factors evaluation and testing, the pre-market review process, and how strong human factors processes should be a part of the design and development of medical devices.
A foundation for applying human factors will be set with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.
MedicalAM 2022 will give participants the opportunity to learn about the latest innovations, advancements and projects all taking advantage of advanced materials within the Medical and Healthcare sectors.
From orthodontic and orthopaedic to cardiovascular and dental procedures, advanced materials have been used in the innovation, design and manufacturing of medical devices and applications throughout the world for decades.
Switching to single-use endoscopes can help healthcare organizations lower risk of infection transmission and achieve greater cost savings. This webinar will explore the history of single-use endoscopy in the context of other healthcare paradigm shifts and will examine evidence supporting a single-use endoscopy future.
The Global Conference on Pharma Industry and Medical Devices (GCPIMD) is to bring together innovative academics and industrial experts in the field of Pharmacy and Pharmaceutical Science to a common forum. The primary goal of the conference is to promote research and developmental activities in Pharmacy and Pharmaceutical Science. Another goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in Japan and abroad. The conference will be held every year to make it an ideal platform for people to share views and experiences in Pharmacy and Pharmaceutical Science and related areas.
BioT Medical & Orthogonal partner to provide expert opinion and discuss the new frontiers of medical device connectivity in an exclusive webinar powered by MedTech Intelligence.
Connectivity of medical devices to the cloud is becoming a reality and poses many challenges for device manufacturers. In this webinar we shall discuss how device manufacturers can address the connectivity challenge and turn it into an opportunity by going beyond connectivity to create direct-to-consumer personalized connected care solutions that directly impact the perceived reported outcome of the treatment. We shall address considerations around building such a connected care solution and how to achieve it in a short timeframe.
This webinar will highlight:
Key elements of a connected care system.
Considerations around building a connected care solution.
Reducing costs and time to build using a no-code approach.
Creating personalized patient experiences using out-of-the-box tools.
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Medical equipment that directly delivers therapy – such as through infusion, transfusion, dialysis, or ventilation – can significantly benefit from clinical software solutions.
While connectivity is now a given for new equipment in hospitals, many vendors still struggle to effectively capture and use data from their devices to improve patient outcomes, increase efficiency of clinical procedures, and reduce maintenance. Challenges typically arise beyond the device, where medtech companies have less experience, such as in integration with EHRs, data analytics, SaMD development, cloud-based deployments, and service provisioning.
Considering technological developments to regulatory and medical changes, Peter Matthewson, Head of Electronic Engineering, explains why we need to design devices that can be updated and stand the test of time.
Setting the standard on how the industry should connect and exchange ideas, the American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, product development, innovation, technology, and quality/ regulatory aspects of medical devices.
Participants will understand FDA expectations regarding successful submissions and inspections, recalls, problem-solving, and risk avoidance, and scientific theory and principles of radiation sterilization. The course examines the global ANSI/AAMI/ISO 11137 series on radiation sterilization standards. Participants will learn integration of industry standards with the Quality System regulation, auditing processes for contract laboratories and sterilizers, and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations
For over 30 years, the ISC has been the key conference for our sector, providing updates and information on changing regulations and standards for medical devices and related healthcare products across the globe.
October is Breast Cancer Awareness Month. In recognition of this awareness month, we are highlighting Innovative companies, like KUBTEC, that continue to challenge the status quo of breast cancer.
The MedDev Day, organized by LS Academy has reached its third edition, and will once again serve as a central meeting place for the medical technology industry, bringing together lecture forums, interviews, workshops, and networking opportunities. The event will be a 360-degree overview of the evolving context of medical devices, in-vitro-diagnostics, and software.
International Conference on Health Monitoring Systems, Devices, and Technologies aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of Health Monitoring Systems, Devices and Technologies. It also provides a premier interdisciplinary platform for researchers, practitioners and educators to present and discuss the most recent innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the fields of Health Monitoring Systems, Devices and Technologies.
International Conference on Implantable Medical Devices, Security and Privacy aims to bring together leading academic scientists, researchers, and research scholars to exchange and share their experiences and research results on all aspects of Implantable Medical Devices, Security and Privacy. It also provides a premier interdisciplinary platform for researchers, practitioners and educators to present and discuss the most recent innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the fields of Implantable Medical Devices, Security and Privacy.
This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for the United States (U.S.) and Global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and improved devices to the U.S. marketplace.
This year’s event will be hosted on 23rd June 2021 on our brand-new virtual platform. This event is a must-attend in the calendar for those involved in medical device trials. We have built on last year’s incredibly successful virtual... View Article
HDOs struggle to manage many different cyber risks and vulnerabilities in their organizations. Medical Device, IoT, and Imaging equipment risks can be some of the most elusive risks to quantify, prioritize, and ultimately mitigate the risk. Medical devices, IoT, and imaging devices are used and managed differently vs. traditional IT devices and endpoints. In this talk, we will explore these challenges and how successful organizations approach these challenges and mitigate the risks.
This training aims to deepen the audience’s understanding of common user interface (UI) design errors in modern medical devices and their impact on device safety. It will also introduce the audience to the fundamentals of model-based risk analysis and design to systematically identify, mitigate, and prevent UI software design errors. From this class, the audience is expected to acquire the necessary knowledge and establish the critical thinking for UI design safety and quality that complies with related international standards and FDA guidance.
Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.
Amidst the COVID-19 Pandemic, Medical Device Marketers still face several challenges and are refining their marketing strategies throughout the remainder of the year. With trade shows canceled and face-to-face customer engagement is non-existent, medical device marketers are forced to figure out how to best market themselves in a virtual world while fine-tuning their 2021 budget.
This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.
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