Welcome to a two-day course in product development and regulations for medical technology and in vitro diagnostics. The course is aimed at people who are interested in gaining an overall understanding of how the regulations affect product development in medical technology and in vitro diagnostics.
Day 1
- Introduction – The regulatory framework for medical devices
- The different phases of the product development process, as well as deepening within:
- Risk management
- Usability
- Requirements Management
- Design Review
- Quality system requirements
Day 2
- Regulatory strategy and classification
- Clinical evaluation
- Technical file – Documentation for CE marking. Traceability.
- Requirements for standalone software / “Apps”
- FDA’s Product Registration Requirements.
Exercises:
- Regulatory strategy, including classification, standards, intended use and application specification (from usability)
- Initial Project Plan Risk Management Plan
- Requirements Management, Verification and Validation
The course is open to all and will be conducted in English if any of the participants need this, otherwise the lectures will be in Swedish. Please indicate in the application under Additional details if you wish that the lecture is in English.
Price:
- Incubator company at UBI: free of charge but a de minimis of 3 500 SEK
- Employees within the academy/country council or incubator case at UBI: free of charge
- For others: 3 500 SEK per participant (maximun 2 participants per company)
The deadline for registration is 6 February at 12:00. Cancellation after February 6th, the full cost will be charged.
In addition to the lectures, the price includes lunch and coffee/tea during both days.
Lecturer
Tomas Camnell is working at Symbioteq Kvalitet AB and has 22 years of experience in QA / RA advice, consultation and training in medical technology and biotechnology.
Tomas has 7 years experience as a Project Manager in the Life Science area.
Tomas has experience and background as a line manager for international activities within Amersham Biosciences, responsible for building the business during a very expansive period when sales went from 40 million to over 80 million in one year. Line management, including responsibility for product managers, project managers, product specialists and responsibility for major subcontract suppliers in Sweden, England, France and the United States.
Tomas also has experience as R & D manager and QA manager in the medical device industry, at Ascendia Medtech among others.
Head of production at Stille AB for nearly three years.
Described as an active leader and a supportive colleague with a great ability to create good relationships and good communication at all levels in the international context.
