CE MARK PROGRAMME

CE marking is a declaration by the manufacturer that a product satisfies appropriate provisions of the relevant legislation in Europe. The CE marking demonstrates that a manufacturer has implemented appropriate European Regulation and Directives and the relevant authorities have authorised access to the European market.

For medical devices whether your business is a large blue-chip organisation, SME or start-up company, QFI can guide and assist with the many steps to attain CE Marking whereby we can assist in numerous ways notably:

  • Medical device classification
  • Appropriate Notified Body selection
  • Communication with Competent Authority where necessary
  • Essential Requirements Compliance
  • Identify applicable harmonised standards and help ensure conformity with them
  • Support implementing and maintaining ISO 13485 and ISO 9001 quality systems
  • Construct labelling, packaging, brochure and Instructions for Use
  • Conduct hazard evaluations, risk assessment and management
  • Performance evaluation design and management
  • Clinical investigation design and management
  • Vigilance Procedure and Post Market Surveillance development and execution
  • Produce Design Dossiers where necessary
  • Act as an Authorised Representative
  • Improve and compile the entire CE Technical file
  • Expedite submissions to the relevant authorities
  • Register medical devices with the appropriate Competent Authority
  • Provide on-site regulatory support during Conformity Assessment by Notified Bodies including EC design-examination

QFI has significant experience in bringing a wide range of products to the European market, including:

  • Cardiovascular devices
  • Orthopaedic devices
  • Active and non-active implantable devices
  • TSE and animal tissue-derived products
  • Medical-electrical devices
  • Devices containing radioactive material
  • Borderline devices
  • Nanotechnology devices
  • Wireless devices
  • Medical device software including stand-alone and Cloud
  • Bluetooth devices
  • In vitro diagnostic products
  • Drug-device combination products
  • Wound healing products
  • Continence devices
  • Regenerative medicine
  • Breast implants
  • Personal protective equipment
  • Cosmetic products
  • Other permanent implants
  • Cognitive psychology

Additionally, we can produce high-calibre usability and human factors engineering files and evidence, support user and post-market studies and evaluations, as part of structured surveillance programmes.

QFI also conducts detailed medical device risk analysis to exerting standards, complying with leading standards and practices, safety and reliability engineering and health service standards.

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