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.

We have experience in managing development projects for a variety of products from hardware via software, connectivity, and cloud solutions to the next level of AI and machine learning.

AFRY is certified according to ISO9001, and the division Industrial and Digital Solutions also have a certification according to ISO 13485:2016, Services within the design and development of medical devices.

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
medical devices

Further information about medical device products

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Jörgen Simonsson - Business Unit Manager Product & Software Engineering

Jörgen Simonsson

Business Unit Manager Product & Software Engineering

Contact Jörgen Simonsson

For sales enquiries, please complete this form. For all other enquiries, please visit our office and contacts page here.
Johan Rössner - Business Segment Manager

Johan Rössner

Business Segment Manager

Contact Johan Rössner

For sales enquiries, please complete this form. For all other enquiries, please visit our office and contacts page here.
Karolina Odeblad - Section Manager Product Development

Karolina Odeblad

Section Manager Product Development

Contact Karolina Odeblad

For sales enquiries, please complete this form. For all other enquiries, please visit our office and contacts page here.

Our competencies

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