Medical Engineering

Medical devices

EXPERIENCE THAT MATTERS​

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.

Kim Raabymagle PharmaRelations

SERVICES

  • 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

Life Science consultant concentrated

Services

  • 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.

This website use cookiesfor statistic and user experience.

Pharmarelations uses cookies to improve your user experience, to give basis for improvement and further development of the website and to be able to direct more relevant offers to you. Please read our personal data policy. If you agree to our use, select Allow All. If you want to change your choice afterwards, you will find that option at the bottom of the page.

Cookies