Quality/Regulatory

Medical Device Recall Activity at Highest Levels in Two Years, Is COVID-19 Responsible?

By Maria Fontanazza, Editor-in-Chief

Medical device recalls were up more than 31% during Q2 2020, activity that suggests recalls will reach 1200 by the end of the year, according to Stericycle’s latest recall report.

Product Development

Four Tips for a Productive Supplier Partnership

By David Franta and Del R. Lawson, Ph.D., 3M’s Medical Solutions Division

Managing how a material can affect a device’s success starts with a strong, collaborative relationship with your materials supplier, which can help prevent a myriad of issues throughout the development of medical devices.

Business Analysis

Cybersecurity, COVID-19 and EU MDR Hot Topics of the
2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

Injection Molding Material Selection Guide for Medical Devices

Selecting the right material for your medical device can be a challenge. First, learn several traits of injection molded materials and how these will reflect in your medical device application, for example, hardness, flexibility, chemical resistance, cost, etc. Once you know the traits your medical device requires, you can review the different materials to fit your application. Review this information to make the best material selection for your medical component or device.

Operations

Why Healthcare Facilities Need Historical Analytics

By Roger Sands, Wyebot, Inc.

Devices in healthcare facilities support mission critical processes. Any issue that degrades network performance can have serious consequences.

Quality/Regulatory

Managing Testing Strategies Under the EU MDR

By Robert Przygoda, Adventure Biocompatibility Consulting and
Sherry Parker, WuXi AppTec Medical Device Testing

Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.

EU MDR Postmarket Surveillance & Postmarket Clinical Follow-Up

September 9, 2020 | Webcast

This webinar focuses on:

• How do you maintain compliance in a complex and dynamic environment?
• How does a company shift to active surveillance, generate and review all of the necessary reports, and establish the infrastructure to support these procedures?
• What is “sufficient” evidence in post-market clinical follow-up (PMCF), and how does one collect data for the life of products, particularly legacy or low risk devices?
• What are best practices for the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR)?

Register Now!

Ameing for Asia

Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge

By Ames Gross, Pacific Bridge Medical

In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.

Software and Digital Health under EU MDR

September 16, 2020 | Webcast

Even companies that are successfully managing other aspects of EU MDR still wrestle with the challenges of software. Most software currently in Class I will be upclassified, requiring the establishment of a certified quality system and notified body involvement. There is confusion about current and evolving device and system standards and guidances and their relationship to the new regulatory requirements, and significant ambiguity about emerging technologies, cybersecurity, data privacy, interoperability, and risk management.

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Featured Quote

Given the high priority that biomedical organizations must place on compliance management and the amount of documentation they must produce to support and fulfill regulatory mandates, risk is elevated for those operating with an antiquated QMS.

— David Jones, AODocs

The engineer’s guide to wearables

Sponsored By 3M

“Doctor’s orders” used to be the be-all, end-all. Today, it’s common for patients to seek multiple opinions, highly-tailored treatment options and ways to monitor their health themselves. Wearable medical devices have been game-changers – especially for people with chronic illnesses. Wearables enable patients to have constant access to health data that allows them to make critical health decisions from the comfort of their own homes or on-the-go.

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Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers

Sponsored By Evidera

Gone are the days of selling med tech products to surgeons and physicians based on relationships alone. Today, surgeons must convince hospitals that a new product provides clinical and economic value, and manufacturers must arm surgeons with evidence to facilitate successful discussions with hospital value-analysis teams (VAT).

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The Growing Need for Real-World Evidence in Medical Devices

Sponsored By Evidera

Derived from a wide range of data sources, real-world evidence (RWE) is used to complement clinical trial data to create a robust evidence base showing both safety and efficacy in defined populations (clinical trials), as well as outcomes in the general populations.

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• Medical Device Audits, Certification & Verification
• Quality & Regulatory Market Access Solutions
• Medical Device Component
  sponsored by 3M
• Medical Recall