A person holding a tablet displaying an electrocardiogram

Services we offer

Malsen Medical assists medical and pharmaceutical companies to bring their products to market and stay there. We ensure product conformity and we expertly put in place complex systems that need the coordination of a multidisciplinary team. Malsen Medical have a wide network of European experts to ensure best practices throughout all regulatory processes. 

Areas of engagement

We are currently involved in a variety of projects, these include:

  • Qualification and validation of pan-European software systems according to GAMP5
  • MDR remediation of technical files and QMS
  • Build and certify Quality Management Systems according to ISO 13485 and other required standards
  • Risk management according to ISO 14971
  • Electronic document controls according to part 11 rule
  • Implementing workflows for streamlined production
  • Project planning, coordination and execution
  • Supporting funding processes in a national and European context
  • Market analysis and development
A person holding a tablet displaying an electrocardiogram