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  • Welcome to gainspeed Ltd,

    CE Marking Specialists


    A South Wales based Product  Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations


  • Specialists in EMC and Low Voltage

    (Safety) Directives


    We specialise in European and Worldwide approvals.

  • Flexible, Professional, and Affordable Service


    We are a small organisation employing only

    highly experienced associates.

Author Archives: Gainspeed

ETSI standards free gap analysis

ETSI have released some extremely useful gap analysis documents for a range of popular ETSI standards. Using these documents it’s a simple exercise identifying important changes that could affect your compliance requirements.

https://portal.etsi.org/Services/editHelp!/Tohelpyouinyourwork/Services/ComparedversionsofETSIHarmonisedStandards.aspx

NOTE:    All the compared versions are available in PDF version

What is Gap Anlaysis?

Gap Analysis for certification is the process of checking your technical file when the standards its certified to have been updated. Then assessing the changes to evaluate if retesting is required.

Why do i need Gap Analysis?

If a company can identify through a gap analysis that retesting is not required it can save a lot of time and money by not repeating the certification process.

Can a Gap Analysis go in my technical file?

Yes it absolutely should, the document can be used as evidence of due diligence when standards change.

What does a Gap Analysis look like?

Gap analysis is generally a report that identifies the changes and summaries its impact. Gainspeed have carried out lots of gap analysis for its clients, please contact us if you would like us to carry out a gap analysis assessment for you today.

 

New Harmonised standard list for the In Vitro Diagnostic Medical Devices Directive

In Vitro Diagnostic Medical Devices Directive (93/42/EEC)

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

17th November 2017               2017/C 389/04               4 standards added

  • EN ISO 11137-1:2015
    Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
  • 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 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)

 

 

New Harmonised standard list for the Active Implantable Medical Devices Directive

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:

17th 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)

 

 

New Harmonised standard list for the Medical Devices Directive

Medical Devices Directive (93/42/EEC)

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

17th 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)

 

 

Gainspeed Newsletter 2018 Issue 2

Summer is coming!

As always plenty of important information on everything compliance.

lots of new subscribers this year, so if your new to our news letter, then we highly recommend a read. The information contained can save you hours of research and confusion.

With the compliance calendar you can clearly see whats happening in the next few months.

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
Guidance
EMC Directive
Radio Equipment Directive
New EU Regulation
EU Goods Package
SUSTAINABILITY
RoHS – Published extension of expiry dates
New Standards of Interest
EN 61000-4-5 EMC Surge standard updated
EN 61000-4-11 EMC Dips and Interrupts standard updated
Standards Published Recently
February 2018
March 2018
April 2018
Compliance Calendar

Download

 

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