Browse through the list of MD News Updates for 2016

2016 Enews

29 September 2016

BSI achieves accreditation to certify organizations to new ISO 13485:2016 standard >

BSI has been accredited by the United Kingdom Accreditation Service (UKAS) to certify its clients to ISO 13485:2016.

09 June 2016

Agreement reached on new EU rules >

On 25 May 2016, new rules were agreed on medical devices and in vitro diagnostic medical devices.

31 May 2016

2016 EU Medical Device 5th Annual Roadshow >

BSI is proud to host our fifth annual Medical Device Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community.

01 April 2016

Update on European Regulation, Electronic Cigarettes >

There is a great interest in the regulation of nicotine-containing products (NCP), either to help smokers break their dependence to nicotine that comes from tobacco products or simply as a replacement. A relatively recent newcomer is the eCigarette.

26 February 2016

Introducing the new ISO 13485 Medical devices. Quality management systems. Requirements for regulatory purposes >

The latest edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, with over 27,000 certificates globally, has been published today.

12 January 2016

Countdown begins for launch of the new ISO 13485:2016 standard >

The working group met for the final review of the document in September 2015 and agreed final edits prior to issue by ISO/CEN. Find out more.

01 January 2016

Medical Device Single Audit Program >

The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.

21 November 2016

BSI to open a second EU Notified Body based in the Netherlands >

BSI has now commenced application for designation under the EU AMID and Medical Device Directives within the oversight of the Dutch Healthcare Inspectorate

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2016 Enews