Recently the FDA (United States) has released its latest List of Recognized Consensus Standards & the EU (European Union) has released updated lists of Harmonized Standards for the MDD (Medical Device Directive), the AIMDD (Active Implantable Medical Device Directive), and
Smartphone Blood Analyzer & Allergen Tester
As we all know smartphones are doing more and more medical tasks including now being able to be a blood analyzer and allergen tester.
Medical Device Audit Training Opportunities
Rob Packard & Brigid Glass have a couple opportunities for you to learn about different aspects of medical device auditing. These offerings are in February & April 2013 and range from a 1 hour audio conference, to a free webinar,
MD&DI Articles on Home Use FDA Draft Guidance & Be Aware
This post deals with the FDA’s Draft Guidance on Home Use Devices. But it is a two for one (two articles and a note from Leo Eisner about the draft guidance to be aware of so really a 3 for
AAMINews on IEC60601-1 Amendment 1
AAMI News: Jan 2013: Excellent Article on Amendment 1 (A1) to IEC 60601-1 Underscores Role of Safety in Device Design.