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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)

 

 

New Low Voltage Directive Guidelines

The European Commission has published new guidelines on the application of the LVD directive its a valuable resource to aid in the understanding of the LVD

This version replaces the previous version of November 2016. This guide has been prepared by the competent services of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (GROW) of the European Commission in cooperation with Member States, European standardisation bodies, European industry, European consumer organisations and other relevant sectoral stakeholders.

The structure of the LVD guide follows the structure of the LVD itself. Comments and explanations are given to each Article and Annex of the LVD. It also provides additional clarifications and information in Annexes VII-XI. For comprehensive guidance on horizontal terms and principles of EU product rules, the readers should refer to the ‘The ‘Blue Guide’ on the implementation of EU product rules”, as advised in the guidelines.

The Guide is available on the EU website here