Medical Device

Medical Device

EXPERIENCE THAT MATTERS​

We are a strong team with long experience covering quality and regulatory management for medical devices. With the base in ISO 13485, ISO 14971, MDR and IVDR as well as additional applicable standards. 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, medical device, software, and combination products.

Kim Raabymagle PharmaRelations

SERVICES

  • QA/RA manager, including Person Responsible for Regulatory Requirements (PRRC)
  • Qualification and classification according to MDR and IVDR
  • CE-marking
  • Regulatory strategies
  • QMS management - construction, implementation, and maintenance according to ISO 13485 and MDR/IVDR article 10
  • Planning and compiling technical documentation according to requirements in IVDR and MDR
  • General Safety and Performance Requirements (GSPR)
  • Internal audits for ISO 13485 and MDR/IVDR
  • Supplier audits
  • Support during third party audits

Life Science consultant concentrated

SERVICES

  • MDR and IVDR requirements for importer and distributors
  • Risk management according to ISO 14971
  • Post market surveillance, vigilance handling and CAPA management
  • Life cycle management, e.g. change control, complaints and deviations
  • Tailored training programs, for example in MDR, IVDR and ISO 13485
  • Workshop on different topics
  • Mentoring
  • Notified body sourcing and submission support
  • Support in the contact with the Competent Authorities

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

Our Services

Interim solutions Consulting & outsourcing Executive search Specialist recruitment Audits Nordic market entry PharmaRelations Academy Due diligence Interim Executives

Expertise Areas

Regulatory services Marketing Compliance Quality Assurance Pharmacovigilance Pharmaceuticals Supplements & Food Cosmetics
Medical Affairs Medical Writing
Sales & Marketing Digital & Social Media Data & Technology
Pre-clinical services Clinical development
Medical Engineering
Market Access
Medical Device

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