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Standards & Guidance Update
Medical Device Sterilization Training
7th July 2011 – Gamma & E-beam (advance) & 13th July 2011. – Ethylene Oxide (advance)
1 day courses at …
GHTF officially endorses the use of the GMDN nomenclature system
GHTF have issued a position statement on the Single Global Nomenclature System for Medical Devices. In a statement (see below) …
GHTF publish additional guidance on auditing of QMS
The Global Harmonization Task Force (GHTF) have published additional guidance as follows:
- SG4/N30 2010 Guidelines for Regulatory Auditing of QMS
…
Formal voting on final version of ISO 14155 Clinical investigation of medical devices for human subjects
ISO committee has published the FDIS for ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical …
ISO 14644-9 is now published as an FDIS
On 8th July 2010, ISO published 14944-9 “Cleanrooms and associated controlled environments — Part 9: Classification of surface cleanliness by …
MEDDEV 2.4/1 Now at Revision 9: Classification of Medical Devices
Guidance Document MEDDEV 2. 4/1 became Rev. 9 in June 2010. The changes have come about due to Directive 2007/47/EC…
Updated list of harmonized standards
Europa has updated the harmonised standards list on 7th July. Details can be found at
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:183:0015:0044:EN:PDF…
Future head of IQWiG has a lot to learn about medical device regulation
Most people who work in the medical device arena know how regulated it is. But it would appear that even …
BS EN 285:2006+A1:2008 revised standard published
The revised standard for steam sterilization has been published this month. BS EN 285:2006+A1:2008 Sterilization. Steam sterilizers. Large sterilizers now …
Biological Evaluation of medical devices EN ISO 10993-1:2009 confusion
In June 2009, CEN published EN ISO 10993-1:2009. This standard is identical to ISO 10993-1:2003, except for some informative annexes. …
