Quality & regulatory

Malsen Medical is a trusted long-term partner for medical device companies for quality and regulatory services.


Our competence
Extensive experience in QA processes
Tailored to your specific requirements
High-quality results within agreed-upon timelines


QMS Build-up
Designing and executing quality systems for Pharma, MedDev and IVD.

QMS Remediation
Conducting reviews of QMS
Enhancing internal processes
Ensuring adherence to ISO 13485 standards

Operative QA
Provision of specific roles, e.g. PRRC and Quality Manager
Quality Events and Change Management

Regulatory affairs

For startups and new projects

  • Regulatory strategy and planning
  • Complete list of regulatory documents from concept to global launch
  • Interactions with EU and FDA
  • Compilation of technical file / design dossier

For operations

  • Evaluation and support for product and cirumstancial changes
  • Strategies for entering new markets (both regulatory and commerical)

Contact the expert

Want more information? Contact us directly by phone or email. Alternatively, simply complete the short form below and we’ll get back to you.

Gergana Georgieva

Gergana Georgieva

+47 465 34 887

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Success stories

Scientist holding chip


A medical IT company that markets the product Spirare used by health care professionals to visualize and manage data gathered from several modalities. 

Malsen Medical created the technical file for compliance to MDD and associated QMS. Full compliance to IEC 62304 in context of MDR with a certified ISO 13485 QMS will help ensure continued business stability and growth. 

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