Medical Device Quality Management Support

Medaptivo’s dedicated staff will help you to prepare the appropriate documents and ensure compliance with the requirements of MDR, MDSAP and ISO 13485:2016. We provide a broad level of support in the following areas:

  • QMS development and implementation for start-up companies
  • Standard Operating Procedures (SOPs) and Work Instructions (WIs) writing, update, and review
  • QMS document design and update, including Corrective and Preventive Actions (CAPA), Non-Conforming Product and Customer Complaint Forms
  • Distributor/Importer/Authorized Representative/UK Responsible Person Agreement generation and update
  • Internal Audit Schedule and Report templates generation

Find Out What We Can Do For You

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