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Upcoming Events & Webinars

- Open for Registration.
- Complimentary
March 12, 2021 – 1:00 pm – 2:00 pm
Medical Device Regulation – MDR Transition Update

With the application date fast approaching, gain insights into the new MDR requirements. Following the webinar, you will be better prepared to meet the increased requirements that have been placed on medical device manufactures. You will gain an understanding of your next steps, whether it is additional MDR transition training, or what to discuss with your notified body.

March 30, 2021 – 12:00 pm – 2:30 pm
EU IVDR Introduction (EU IVDR Innovation in Practice Virtual Event Series)

The reclassification of diagnostics under EU IVDR means that many companies, particularly those with previously self-certified products, face tremendous new challenges in complying with strict regulations and working with notified bodies. This introductory webinar provides an overview, timeline, new classification system, and procedures for working with notified bodies.

April 6, 2021 – 12:00 pm – 2:30 pm
Quality Processes and Documentation (EU IVDR Innovation in Practice Virtual Event Series)

EU IVDR requirements demand significant changes in company quality procedures, management oversight, risk assessment, and documentation. This session outlines major changes, their impact, and strategies for implementation.

April 13, 2021 – 12:00 pm – 2:30 pm
Clinical Evidence & Surveillance (EU IVDR Innovation in Practice Virtual Event Series)

The most demanding requirements imposed by EU IVDR concern clinical and performance evaluation, even of legacy products, and stringent ongoing postmarket assessments. Some confusion remains about procedures and expectations, and our speakers discuss best approaches and strategies.

April 20, 2021 – 12:00 pm – 2:30 pm
Supply Chain Management: Economic Operators, UDI, and Labeling (EU IVDR Innovation in Practice Virtual Event Series)

EU IVDR requires substantial and challenging changes in relationships with suppliers, distributors, and other economic operators, as well as changes to all labeling and new traceability requirements. These can be some of the most costly and troublesome aspects of EU IVDR, and companies should plan quickly and carefully.

April 27, 2021 – 12:00 pm – 2:30 pm
Strategy and Planning (EU IVDR Innovation in Practice Virtual Event Series)

EU IVDR implementation is not merely a question of changing a few SOPs. It requires a portfolio review of legacy products and substantial changes from the top down in organizational structure and processes. Learn from experts who have already gone through IVDR implementation, know where the greatest costs and stumbling blocks lie, and offer strategies for effective project management.

On Demand Webinars

(Alpha by title)

- Available for Purchase.
- Complimentary
August 20, 2020 – 1:00 pm – 2:00 pm
2021 – Preparing for Changes in the EU MDR Complaint Management and Vigilance Regulations

Whether a manufacturer, authorized rep, importer, distributor, user or health professional, learn the definitions, terminology, reporting timeframes and other changes critical for assuring compliance with EU-MDR/IVDR vigilance regulations.

February 10, 2021 – 1:00 pm – 2:00 pm
Bringing Digital Transformation to Your Supply Chain: Connecting OEMs & Contract Manufacturers for Improved Performance

The unrelenting supply chain challenges in the medical device manufacturing industry today are bringing the working relationships between OEMs and contract manufacturers into sharp focus. Both partners have to address inconsistencies and disruptions that impact a host of day-to-day functions such as planning, procurement, manufacturing, quality, inventory management and logistics. Join us for this web seminar to learn how a modern, connected supply chain solution can help you.

January 27, 2021 – January 27, 2021
Computer Modeling & Simulation in MedTech Product Development & Submissions (Day One)

This two-day virtual conference provides a comprehensive overview of what computer modeling & simulation can and cannot do, the potential advantages throughout the product life cycle, the business case for simulation, FDA’s views on in silico data in regulatory submissions, and demonstrations and case studies of its use in diverse applications.

January 28, 2021 – January 28, 2021
Computer Modeling & Simulation in MedTech Product Development & Submissions (Day Two)

This two-day virtual conference provides a comprehensive overview of what computer modeling & simulation can and cannot do, the potential advantages throughout the product life cycle, the business case for simulation, FDA’s views on in silico data in regulatory submissions, and demonstrations and case studies of its use in diverse applications.

December 16, 2020 – 1:00 pm – 2:30 pm
Connected Medical Devices & the Cloud

The growth of public cloud computing platforms such as Amazon Web Services, Microsoft Azure, and Google Cloud has been driven by a wide variety of benefits related to reliability, performance, scalability, security, convenience, cost and functionality. Seeking to capture these benefits, more medical device companies are placing key components of medical device software and functionality on public cloud computing platforms, which creates challenges. Experts will share an emerging set of best practices that address these challenges so that medical devices can harness the full benefits of cloud computing.

July 28, 2020
Defend Against MedTech Cyber Breach: A Fireside Chat with Critical Healthcare Stakeholders

What is your role in keeping patients safe, securing data privacy, and reducing potential liability from cyber breach through the connected devices you prescribe, design, or distribute? Join security leaders from Partners Healthcare, GE Healthcare, Zipnosis, and Irdeto for a discussion of point-of-care-wide best practices and current technology solutions to defend against potential risks and dangers to your patients and your organization.

May 21, 2020 – 1:00 pm – 2:00 pm
Emergency Use Authorization (EUA)

Many medtech companies are working with FDA to secure EUAs for their products to help address the COVID-19 pandemic. An EUA can offer insight into the "new normal" healthcare market that will emerge post-pandemic. Attendees will learn insights on navigating the regulatory process with FDA, steps for implementing quality by design in crisis mode, strategies for sourcing, manufacturing, and distribution in spite of a broken supply chain, and how to push across the finish line, to ensure that these products get to clinicians and their patients when they need them.

May 20, 2020 – 1:00 pm – 2:00 pm
Improving the safety, visibility & transparency of your supply chain during a crisis to sustain customer confidence

Supply chains have been disrupted, regulatory authorities are applying more pressure, more employees are working remotely, and investors are still demanding growth. Join us on this upcoming webinar to learn how a holistic approach to manufacturing, compliance and quality supported by single, modern cloud platform leads to improved operations and enables enhanced growth and why it’s a sound strategy for these uncertain times.

February 9, 2021 – 1:00 pm – 2:00 pm
ISO 14971:2019 Risk Management for Medical Devices

This risk management training webinar provides an overview of changes to the risk management standard (ISO 14971:2019), the associated guidance documents (ISO/TR 24971:2020), and the new European Requirements as outlined in Annex I of Regulation (EU) 2017/745. During this webinar you will learn the difference between a process risk analysis and the risk management activities associated with design of medical devices. You will also learn how to create a risk management plan.

March 12, 2021 – 1:00 pm – 2:00 pm
Medical Device Regulation – MDR Transition Update

With the application date fast approaching, gain insights into the new MDR requirements. Following the webinar, you will be better prepared to meet the increased requirements that have been placed on medical device manufactures. You will gain an understanding of your next steps, whether it is additional MDR transition training, or what to discuss with your notified body.





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