6 Questions to Ask Yourself about ISO 11607 Compliance

These FDA-consensus standards guide packaging design and validation—how compliant are you, and how ready are you for the upcoming revision?

FDA Medical Device Safety Action Plan: Good or Bad for Medtech?

FDA’s five-pronged Medical Devices Safety Action Plan, revealed in April, has triggered concern by AdvaMed, Johnson & Johnson, and physician specialty groups.

Should Medical Devices Come with Expiration Dates?

Implantable medical devices containing highly sophisticated electronics are lasting longer than before, raising the bar for safety and liability.

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Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

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Is FDA Getting More Cozy with AI?

FDA’s recent approval of stroke detection software paves the way for Artificial Intelligence applications to thrive on the healthcare landscape.

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Get Answers to Your Usability Testing Questions

A live demonstration of formative usability testing at MD&M East aims to share best practices and answer attendee questions.

New EU MDR Regulations and Revamp of the Medical Device Directive

An overview of the key impact points and challenges of European Union Medical Device Regulation.

Act Now to Prepare for MDSAP Audits

The clock is ticking for medical device manufacturers worldwide. Manufacturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the international Medical Device Single Audit Program (MDSAP) by now. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019. On that date, companies selling Class II, III, and IV medical devices and IVDs must have an MDSAP Certificate on file with Health Canada to maintain their Canadian Device Licenses.

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paperStrategic Priorities paper that FDA’s CDRH released today.

FDA Exempts Over 1000 Devices from 510(k) Requirement

The 21st Century Cures Act paved the way for deregulation of a host of medical devices ranging from surgical lights to dentures.