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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.

Category: News

Our November 2015 Newsletter packed with latest Compliance news!

Updated on date by author

Your free comprehensive guide, perfect for saving you time.

Were very proud to announce the Gainspeed news letter is here. Its a friendly complimentary newsletter on everything compliance.

Some of this months features.

Standards Watch

  • European standards being withdrawn
  • EU Directives changing
  • Lists of European Harmonised Standards
  • Recycling Symbols (1)
  • The “crossed out wheelie bin”
  • Compliance Calendar
Posted in News, News Letter |

May Gainspeed newsletter packed with latest Compliance news!

Updated on date by author

The new May Gainspeed newsletter is here. Its a friendly complimentary newsletter on everything compliance.

Some of this months features are.

Headlines

  • Standards Watch
  • European standards being withdrawn
  • EU Directives changing
  • Lists of European Harmonised Standards
  • The Blue Guide 2016 –
    What Directives does the Blue Guide cover
  • A Reminder LVD (2014/35/EU) – “adequate analysis and assessment risk”
  • Compliance Calendar
Posted in News, News Letter |

New version of the CE Marking, “Blue Book”

Updated on date by author

Just a reminder! – the European Commission published a “new” version of “The ‘Blue Guide‘ on the implementation of EU product rules 2014″, (the so called “Blue Book“), in July this year

The new ‘Blue Guide’ builds on the on the content of the Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) published back in 2000, but reflects the modernisation brought to the legal framework in the past decade.  

This is not an update as such, as there has been no change to the content – the only difference is in the formatting

Posted in CE Marking, News |

NMRO – Guidance to RoHS Directive 2011/65/EU

Updated on date by author

Updated guide from the NMRO available on line

The aim of the National Measurement and Regulation Office (NMRO) is to simplify technical regulation for the benefit of British business.

Key changes are:

• the inclusion of the new banned substances (DEHP, BBP, DBP & DIBP),

• the updating of web references

• A new Appendix 3 Legislative references

Take care, there are some errors
Appendix 2 “Exemptions: other applications”
The exemptions for “Lead” and “Cadmium” are incorrectly identified as “Mercury exemptions” in the table on pages 27 through 32.

Posted in News, RoHS Directive |

Final draft of ISO 13485 circulated

Updated on date by author

ISO/FDIS 13485 Medical devices — Quality management systems — Requirements for regulatory purposes Final draft of ISO 13485:2015 has been circulated and is available from BSI:

ISO 13485:2015 is due to be published early 2016.

The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire life cycle of a medical device.

Some of the key changes include:

* Harmonization of regulatory requirements
* Inclusion of risk management throughout the QMS
* Additional clarity with regard to validation, verification, and design activities
* Strengthening of supplier control processes
* Increased focus regarding feedback mechanisms
* Software for QMS, manufacturing and the medical device
Additional information available from BSI:

* Download the BSI white paper on ISO 13485 – The proposed changes and what they mean for you

* Learn more about the ISO 13485 revision

Posted in New Standards/Directives, News |