Medical Device Regulatory Consultancy & Expertise

Whether you are a manufacturer, importer or distributor, Medaptivo have the required capabilities and experience to help you establish compliance with existing directives, as well as new regulations. We do this by looking at your individual needs, identifying gaps and areas of improvement and implementing customised compliance solutions and strategies.

Services and solutions include, but are not limited to:

  • MDR CE Marking
  • MDD-to-MDR Transition, Planning & Implementation
  • MDD/MDR Technical Documentation Reviews & Gap Assessments
  • MDD/MDR QMS Gap Assessments
  • Generation & Update of Technical Files/Dossiers
  • Clinical Evaluations Reports (CERs)
  • Risk Management Files
  • Biological Safety Evaluation Reports
  • Post-Market Surveillance Documentation
  • Labelling, User Manuals & Marketing Brochures
  • Product &/ Company Registration
  • Regulatory Agency Support

Find Out What We Can Do For You

Schedule a Free Consultation