Category: News

Compliance Newsletter October 2017

Updated on

January 31, 2023 by author

Gainspeed

This months Gainspeed Newsletter is here. Its a friendly complimentary newsletter on everything compliance.

lots of important changes this month including some common new standards that have come into effect.

Are you ready? Do you need gap analysis?

We can help, if you want to know more or have any questions feel free to contact us

Some of this months features are.

Headlines
Standards Watch
European standards being
withdrawn
Other standards being withdrawn
Lists of European Harmonised
Standards
SUSTAINABILITY
REACH – where to get
information
RoHS – Applications exempted
from the restrictions in Annex III
New Standards
August 2017
September 2017
October 2017
Compliance Calendar

Gainspeed Newsletter 2019 issue 1

Updated on

January 31, 2023 by author

Gainspeed

Brexit this month… In or out keep up to date on the latest draft UK legislation!

Find out about the “UK Conformity mark” a solution for the UK, if we leave with no deal.

Have questions? We can help, feel free to contact us

Some of this months features are.

Headlines
Standards Watch
European standards being
withdrawn
Other standards being withdrawn
Lists of European Harmonised
Standards
Brexit
Draft UK Legislation
No Deal Brexit – UK Conformity
Assessed Mark
New Standards – a quick
overview
CEN/TR 10364:2018
PD IEC GUIDE 116:2018
New Standards Published
December 2018
January 2019
February 2019
Compliance Calendar

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2019-03-15 13:18:38

New Harmonised standard list for the Medical Devices Directive

Updated on

January 31, 2023 by author

Gainspeed

Medical Devices Directive (93/42/EEC)

There is a new publications in the OJEU of standards harmonised under the Medical Devices Directive:

17^th November 2017 2017/C 389/03 13 standards added, including

EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 14155:2011/AC:2011
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)
EN ISO 15223-1:2016
Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

Posted in Medical Devices Directive, News |

Gainspeed Newsletter 2019 issue 2

Updated on

January 31, 2023 by author

Gainspeed

Great new guide from ETSI on ”Understanding ICT Standardization: Principles and Practice”,

Have questions? We can help, feel free to contact us

Some of this months features are.

Headlines
Standards Watch
European standards being
withdrawn
Other standards being withdrawn
Lists of European Harmonised
Standards
Brexit
No reliable / consistent
information to report
Guides
How to become an expert with standards
New / updated Standards – details of changes
Amendment 1:2019 to EN 61010-1:2010
ISO/TR 22100‑4:2018
BS EN IEC 62474:2019
New Standards Published
February 2019
March 2019
April 2019
Compliance Calendar

Download

View Online

2019-05-10 16:32:48

Posted in News, News Letter |

New Harmonised standard list for the Active Implantable Medical Devices Directive

Updated on

January 31, 2023 by author

Gainspeed

Active Implantable Medical Devices Directive (93/42/EEC)

There is a new publications in the OJEU of standards harmonised under the Active Implantable Medical Devices Directive:

17^th November 2017 2017/C 389/02 4 standards added

EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 14155:2011/AC:2011
Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011)
EN ISO 15223-1:2016
Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

Posted in Medical Devices Directive, News |