Medical Devices

Are MDR and IVDR causing headaches? Have you faced challenges to demonstrate the clinical safety or performance of your Medical Device? Do you need support for building and developing your Quality Management System?

We help you to safeguard medical device manufacturers and importers regulatory compliance

  • by Providing a professional and experienced Staff at your service
  • by Building, Maintaining and Developing your Quality System that fulfills the requirements of applicable standards (ISO 13 485, ISO 14¬†971)
  • by Auditing your Quality System or Subcontractors
  • by Creating and updating your Standard Operating Procedures and Process Descriptions
  • by Training your staff

Person responsible for regulatory compliance / Quality manager

  • Please ask more for our in-sourcing services

Clinical expertise

  • Clinical Evaluation / Clinical Evaluation Report (CER) and it’s updates
  • Risk Management Plan
  • Post Market Clinical Follow-up (PMCF)
  • Device claims compliance check

Training

  • We tailor training’s for your needs, we support your personnel and give initial training for new employees

Life-cycle management – post market surveillance

  • Post Market Clinical Follow-up (PMCF)
  • Taking care of the trend monitoring and periodic summary reports associated with safety and hazardous situations
  • Handling incident reporting, and help with the planning of corrective measures and the design of the safety data sheet
  • Acting as a contact link between the Manufacturer and Importer

Technical documentation

  • Compilation of Technical Documentation
  • Clinical Evaluation / Clinical Evaluation Report (CER)
  • Helping with classification of your Device
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