Medical Devices

Medical device services to meet your needs

We can help you to safeguard the regulatory compliance of medical device manufacturers and importers by:

  • Providing you with professional and experienced staff
  • Building, maintaining and developing your quality system so that it meets the requirements of applicable standards (ISO 13 485, ISO 14 971)
  • Auditing your quality system and subcontractors
  • Creating and updating your standard operating procedures and process descriptions
  • Training your staff

Clinical expertise

  • Clinical evaluation / clinical evaluation report (CER) and its updates
  • Risk management plan
  • Post-market clinical follow-up (PMCF)
  • Compliance check of device claims

Life-cycle management – post-market surveillance

  • Taking care of trend monitoring and periodic summary reports associated with safety and hazardous situations
  • Handling incident reporting and helping to plan corrective measures and design of safety data sheets
  • Acting as a contact link between the manufacturer and importer

Technical documentation

  • Compilation of technical documentation
  • Helping with classification of your device

 

 

Are you looking for person responsible for regulatory compliance or Quality Manager? Please ask for more details on our in-sourcing services

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Regulatory Affairs        

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