Experts in Quality Assurance and Regulatory Affairs for Medical Devices

Looking for experts to guide your medical device through complex quality and regulatory requirements? Our experienced team has a strong track record in navigating industry standards and achieving compliance.

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OUR 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

 

  • 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.

Emma Axelsson

Head of Medical Device (RA/QA)

emma.axelsson@pharmarelations.com

PharmaRelations

Frösundaviks Allé 1, 169 70 Solna

+46 (0)8 590 745 80

info@pharmarelations.com