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2013 Enews

You are currently viewing all 2013 enews. To view other years, please select below:

2013 Enews

A Double-Dose of Medicine for BSI

BSI is delighted to update you on a significant investment and expansion of our in-house medicinal expertise.

BSI Medical Devices hosts it's first successful forum in Shanghai

BSI China supported by the Global Medical Device team held their first Medical Device Forum in Shanghai.

BSI's approach to reviewing electronic IFUs

Changes to the European / Australian Mutual Recognition Agreement (MRA)

The Australian TGA and European Commission have announced changes in the EU / Australia MRA taking effect January 1, 2013.

CSA Group and BSI form global strategic alliance to offer combined services to the medtech industry

CSA Group expands European electro-medical devices testing services with acquisition of BSI’s German testing business

05 February 2013

EN ISO 14971:2012 - what does it mean for Manufacturers placing products on the European Market?

Read about the changes to EN ISO 14971:2012.

European Medical Device Expert Group Meeting Update

Read about the first MDEG meeting of 2013 held in Brussels.

European Parliament votes on Pre Market Authorization (PMA) elements in high risk device market access

Today, (22 October 2013) the European Parliament made a decision in the first Reading on the future of medical device regulations in Europe.

From California to Boston BSI takes its product experts on the road

Another successful 2013 medical devices roadshow for BSI in America during September. Read more.

Guide to European Medical Device Trials and BS EN ISO 14155

Get your copy of the new ‘go to’ guide for medical device trials.

Interested in supplying your medical devices in the Kingdom of Saudi Arabia?

Learn about the SFDA Market Authorisation.

Malaysian Medical Devices Authority appoints BSI as a Conformity Assessment Body for Medical Devices Act 2012

BSI now registered as a Conformity Assessment Body (CAB).

11 December 2013

Medical Device Single Audit Program (MDSAP)

BSI would like to draw your attention to the MDSAP Pilot Program that is starting in 2014, that will have significant impact on your Medical Device Audits in the future.

Regulation EU (No) 722/2012 – New Regulation regarding medical devices utilizing tissues of animal origin

European Union Commission Regulation No 722/2012 concerning both active implantable medical devices (AIMD) and medical devices manufactured utilizing tissues of animal origin was originally published in the Official Journal of the European Union on 9th August 2012.

Unannounced audits for manufacturers with CE certification

Unannounced audits are coming, and will not be optional for Notified Bodies to perform or for manufacturers to receive. Read more.

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