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European Commission

RAPS & Medicaldeviceslegal.com EU Medical Devices Regulation Chart

This Regulation Chart & the blog post contents is Thx to Medicaldeviceslegal.com and the RAPS Dutch/Flanders chapter.  We are grateful to them for sharing such a valuable tool and hope you get a lot of good use from it too.  All they

leoeisner May 3, 2013 Uncategorized Read more

IMDRF Draft Guidance Doc’s Out for Comment: UDI & 3rd Party Audits

The  International Medical Device Regulators Forum (IMDRF) has been really busy of late, which is a good thing as many in the medical device industry are still wondering if the IMDRF will live up to the “Big Shoes” that the

leoeisner May 1, 2013 Uncategorized Read more

Impact of the Draft report on the EU MDD proposed regulations

This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess

leoeisner April 30, 2013 Uncategorized Read more

Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012.  The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft

leoeisner March 2, 2013 Uncategorized Read more

EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN ISO 15223-1) Ooopppss!

The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, ’13 release and EN ISO 15223-1 Medical devices — Symbols to be

leoeisner February 19, 2013 Uncategorized Read more
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510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC60601-1 IEC 60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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