Medical device development
Cost effective production and quality. ÅF delivers turnkey projects and services.
ÅF is a leading engineering and consulting company within medical device development. We cover every stage in the medical technology product lifecycle, with focus on the extensive regulatory frameworks that must be complied with when developing and launching a medical product. ÅF has worked with products registered in most countries worldwide, and our track record in international regulatory environments is strong.
Quality management system
With profound knowledge within the regulations and guidelines that apply to the pharmaceutical industry, we assist you with set up, review or improvement of existing production processes and fit them to your industry requirements and assist with audits. We are certified according to ISO 9001 and our office in Gothenburg are also certified according to ISO 13485:2012, services and contract development of medical devices.
ÅF supports all phases of the entire product life cycle, from initial idea and development including supply, production, maintenance and support to end of life. We have managed development projects for all kind of products, from therapeutic lasers and microwave systems to sterile disposable products.
Examples of core competence
- Project management
- Requirements management
- Management consulting
- Quality assurance and risk analysis
- Product documentation
- Product labelling and packaging
- Usability engineering
- Software development, embedded realtime devices
- Electronics development and production
- Mechanical engineering, design, material and plastics
Do you want to know more about our offering within medical device? Contact any of us here below.