Medical Device Recalls - A Virtual Conference - October 26-27, 2017

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MedTech Intelligence

Volume 9 Issue No. 42

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

UL - Big Changes to Brazil Inmetro Certification for Medical Devices

Featured Articles

Dr. Lutz RetzlaffWearables Revolutionize
Classic Medicine

By Dr. Lutz Retzlaff

This year’s MEDICA will showcase on current trends and applications in wearable technology.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Dr. D Hates Receiving Inspection, Say What?

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

Simply stated, an inspection needs to add some value; otherwise, what’s the point?


Thomas Maeder, MedTech IntelligenceThe Ultimate QA/RA
Cheat Sheet

By Thomas Maeder, MedTech Intelligence

MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.

Understanding and Overcoming Challenges of Medical AdhesivesUnderstanding and Overcoming Challenges of Medical Adhesives

By Bret Ludwig, Ph.D., 3M

10 factors design engineers must consider when creating stick-to-skin medical devices.

Safeguarding Medical Devices Against Cyber-AttacksSafeguarding Medical Devices Against Cyber-Attacks

By Anura Fernando, UL

By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.


More Articles »

Sponsored Resources

Jama SoftwareExplore Agile’s suitability for safety-critical application development

Thursday, October 19th at 10:00 am PDT | Online

Many medical device companies haven’t realized the benefits of adopting Agile methodologies. Agile can strike a balance between full compliance and successful product releases, but only when developers follow the guidelines outlined in AAMI’s TIR45. Join Jama Software and Kelly Weyrauch, AAMI University instructor/TIR45 expert, for a discussion around Agile best practices for medical device systems and Integrating Agile and Systems Engineering.

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