Medical Device

Medical Device Development

A reliable partner in medical device development when you demand the highest quality

Our dedicated and experienced consultants support you in advanced development and production in an extensively regulated environment.

AFRY supports all phases of the medical technology product life cycle, from initial idea and development including supply, production, maintenance and support to end of life. We are certified according to ISO 9001 as well as ISO 13485:2016, services and contract development of medical devices. We have experience in managing development projects for a variety of products, from therapeutic lasers and microwave systems to sterilisation systems and sterile disposable products.

Examples of core competence:
  • Project Management
  • Quality Assurance
  • Commissioning, Qualification and Validation
  • Quality Management System, ISO 13485
  • Requirement Management
  • Supplier Quality Assurance
  • Risk Management, ISO 14971,  
  • Product Safety Regulations, MDR, IVDR
  • Technical Documentation/ Communication
  • Environment, Health & Safety regulations
  • Change Management
  • Medical device product development
  • Software development, embedded real time and connected devices
  • Electronics development and production
  • Mechanical engineering, design, material and plastics
  • IoT/Connectivity

Jörgen Simonsson

Business Unit Manager Connected Products South

Karolina Odeblad

Section Manager Product Development

Our competencies