2014 Enews archive

2014 Enews

22 May 2014

Amendment 1 to the Third Edition of EN60601-1 is harmonized under the Medical Device Directive (MDD) >

EN 60601-1:2006/A1: 2013 has now been published in the Official Journal of the European Union, making it a harmonized standard under MDD 93/42/EEC.

06 June 2014

BSI Malaysia hosts a successful Medical Device Forum >

BSI held its 2014 Medical Device Forum on 26 May in Malaysia. It covered a broad range of hot topics which are imperative to the medical device regulatory community. Read more about the success of this event.

04 August 2014

BSI Medical Device Forum May 2014, Malaysia >

BSI will be holding a Medical Device Forum in Kuala Lumpur, Malaysia on Monday 26 May 2104. The forum will focus on recent topics from the ISO 13485 Medical Devices QMS revision to the CE Marking Unannounced Visits. Be quick to register as places are limited.

18 March 2014

BSI Unannounced Audits - Frequently Asked Questions >

We have compiled a list of Frequently Asked Questions (FAQs), some of these questions arising directly from the participants in the webinar, to help provide you with a better understanding of the requirements.

22 April 2014

BSI Unannounced Audits - Trial Outcome and next steps >

We have now completed our "trial phase" of conducting several unannounced audits. Read more to find out what the process involved and what the next steps will include.

24 February 2014

BSI Unannounced Audits Webinar - EU Commission Recommendation - 2013/473/EU >

To view the Unannounced Audits webinar slides and hear the recording and stay informed on important updates on unannounced audits please visit our website and register*.

19 May 2014

BSI Update on Restriction of Hazardous Substances – ROHS 2 >

RoHS 2 is an update to the European Directive 2002/95/EC. It will affect producers of Electrical and Electronic Equipment. Read more to find out why.

02 May 2014

CE Marking Medical Devices - Unannounced Audits >

CE Marking Medical Devices – European Commission Recommendation of 24 September 2013 (2013/473/EU)

16 September 2014

ISO 13485:201X - 3rd Revision - Stockholm September 2014 >

Find out the outcome of the Application of Quality Systems to Medical Devices Meeting, Stockholm September 2014.

25 March 2014

Learn more about CE Marking and the Medical Device Directives from our experts >

You are invited to watch our free taster webinar about CE Marking and the Medical Device Directives.

28 July 2014

Nanosilver: safety, health and environmental effects and role in antimicrobial resistance >

Read the final opinion from The European Commission’s non-food Scientific Committee on Emerging and Newly Identified Health Risks, following a public consultation about the safe use and health risks associated with the increasing use of nanosilver.

29 April 2014

Update on ISO 13485:201X – 3rd revision >

ISO DIS 13485:201X is now available for comment - read more to find out how you can get involved.

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2014 Enews archive