Allergan, Ideal Implant Hit with
FDA Warning Letters for Breast Implants

By MedTech Intelligence Staff

The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.

Soapbox

COVID-19’s Impact on the MedTech Industry:
How to Get Through

By Jon Speer, GreenlightGuru

The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.

Abbott’s POC Test to Diagnose COVID-19 May Be Inaccurate, FDA Issues Alert

By MedTech Intelligence Staff

The Abbott ID NOW test may return false negative results.

Soapbox

Essential Data Preparations for AI

By Remco Munnik, Iperion Life Sciences Consultancy and
Steve Gens, Gens & Associates

Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.

Featured Quote

The problem with medical device data is not the collection of data but having the necessary tools to analyze the results in a meaningful way.

— Mark Wasmuth, GMDN Agency

MEDdesign

How Effective Collaboration Can Expedite
Medical Device Design

By Clay Moore, Jama Software

Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.

Soapbox

Illuminating the Shadows:
How Unveiling Five Blind Spots Can Transform Business

By David Gwyn, AMPLEXOR Life Sciences

Whatever the short- and longer-term fallout of COVID-19, organizations will need to come back fighting—with new tools at their disposal and ready to raise their game.

How to Approach Process Validation Changes for Implantable Devices

By Mei Lok and Jessica Sanders, WuXi AppTec Medical Device Testing

Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.

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