CE Marking / Testing / Certification

We can help with all Healthcare CE Marking, Testing & Certification issues, including audits, technical documentation and drafting of CE declarations of conformity.

  • Certification / Regulatory Pathway Services
  • On site consultation, Mock ISO 13485:2016 system and compliance audits
  • Technical File Construction - Technical documentation
  • Product Design reviews and Clinical evaluations reviews
  • Standards Investigation and Change Control Management
  • Risk assessment & development of strategies for risk management and control
  • CE Technical files reviews
  • Quality Systems - ISO 9001: 2015/ISO13485: 2016
  • Training - on-site
  • Essential Requirement Reviews
  • Audit preparation & Registration
  • Access to and approval with European Notified competent bodies
  • Intended use /Classification of devices
  • Label and IFU Drafting and reviews
  • Drafting of CE declaration of conformity