Back to Top
  • 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.

Medical Certification Support

We can help you attain ISO 13485:2016 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices.

This standard is essential for manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements and accreditation to ISO13485 will help ensure that happens.

We can also offer assistance with:320px-CE_Logo2

  • internal auditing
  • supplier auditing
  • FDA audit preparation
  • General advice on quality and regulatory aspects of medical device manufacture

We support multiple organisations in the medical sector and take on projects of any size.

Contact us today to learn more.