Soapbox

I’m Watson, Please State the Nature of Your Medical Emergency

By Daniel R. Matlis, Axendia

Should you trust your health to Artificial Intelligence?

FDA to Develop More Guidance on Pre-Request for Designation Process

By MedTech Intelligence Staff

The process gives sponsors the ability to interact more with FDA.

Featured Quote

A push towards digitization and connectivity is resulting in products that have different levels of vertical integration in the development process to meet a customer’s requirements.

— Joachim Schäfer, Messe Düsseldorf

Quick List: The Update on
ISO 13485:2016

By Maria Fontanazza, Editor-in-Chief

A review of changes made to the standard published earlier this year.

MEDFlix

FDA: Consider Device Context, Not Just Intended Use

By MedTech Intelligence Staff

Think about how your product interacts with systems and users.

Devine Guidance

Another CJO Convicted Courtesy of FDA and DOJ, Oh My!

By Christopher Devine, Ph.D.,
Devine Guidance International

If you ignore the Federal FD&C Act, you’re tempting fate.

Zimmer Biomet Boosts Musculoskeletal Diagnostics with CD Diagnostics Acquisition

By MedTech Intelligence Staff

The deal will further cement the company’s competitive advantage in providing ‘comprehensive musculoskeletal healthcare’.

• Medical Device Audits, Certification & Verification
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• Medical Device Component
  sponsored by 3M

Discover Retail Applications

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ISO 14971 Risk Management: Industry Procedures and Best Practices

Webinar: August 24, 2016 1 PM to 2 PM (EDT)

Risk Management has been a foundational requirement in medical device and diagnostics industries. From the high-level implications in the Medical Device Directives (93/42/EEC and 98/79/EC) to the harmonized requirements of Annexes ZA, ZB and ZC, manufacturers are struggling to implement a compliant system that is also sustainable and practical. This complimentary, 60-minute webinar offers a unique opportunity to hear the latest industry thinking on the implementation of ISO 14971.