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 are certified according to ISO9001, and the division Industrial and Digital Solutions also have a QMS in accordance to ISO 13485:2016, Services within 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