Welcome to Medspero Group of Companies

Auditing & QA

Regulatory Compliance Services

  • To assist and guide and/or represent manufacturer to ensure all the responsibilities complying in accordance to updated UK MDR 2002 regulations.
  • To assist in approval and regulatory compliance of Medical Device and IVD as
  • per the new EU Medical Device Regulation (2017/745)
  • To assist in approval of medical device by In Vitro Diagnostic Regulation
  • (2017/746)
  • To assist in Medical Device Registration Services such as:
  • MHRA Registration for UK market
  • MHRA Classification
  • UKCA or UKNI certification
  • CE to UKCA to UKNI certification
  • CE marking service for EU region