Medical Engineering

Medical devices



We are a strong team with long experience covering quality and regulatory management for medical devices. The team has experience from companies such as small start-ups in more generalist roles to large corporations where specific knowledge is key covering fields e.g. dentistry, ventilation, x-ray, software, and combination products.



  • Quality Strategies and projects
  • QMS management, construction, implementation, and maintenance. 
  • GMP/GDP/ISO13485. 
  • Audits- GMP/GDP/ ISO13485/MDSAP
  • Risk assessments, ISO 14971. 
  • GAP-analysis and CAPA plans
  • Audits- internal, supplier, joint audits, mock-audits
  • Inspections- preparations before inspections from authorities
  • Risk assessments, ISO 14971
  • GAP-analysis and CAPA plans
  • CAPA management
  • Life cycle management, e.g. change control, PMS, complaints, deviations



  • Quality agreements
  • Training programs, GMP/GDP/ ISO13485
  • Regulatory Affairs Market access and registrations
  • MDR, MDD
  • GSPR
  • IEC 60601 family
  • CE-marking – Identify applicable requirements and standards early in the development process
  • Support with the technical documentation and the classification of the device
  • Notified body submission support
  • Authority contact and support
  • IVDR
  • Training

We can also provide other services, please contact us for a discussion on how we can help you.

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