Design control/product development – requirements in standards and laws
Description
The medical device industry is shaped by short cycles of innovation. Product development must be driven both effectively and quickly. On the other hand, a range of requirements set out in standards and laws exist; these need to be met during the development phases and verified in corresponding documentation.
Shaping design control processes so that they are workable while taking into account all the requirements that apply to the processes and documentation is challenging. The seminar sets out the requirements relevant to this issue and how they can be implemented cohesively in practice.
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Goals
This seminar explains the requirements for the design control process (development process) that are set out in standards and laws. When doing so, particular reference is made to the requirements in ISO 13485:2016 and Regulation (EU) 2017/745 on medical devices, as well as 21 CFR Part 820 (FDA). The implementation of these requirements is explained using the actual sequence of a development project, including the necessary development stages and documentation. In this context the supporting processes "risk management" (as per EN ISO 14971) and "application of usability engineering to medical devices" (as per EN 62366-1) are explored in more detail.
Seminar content
- Regulatory and standard-based specifications for product development in the medical technology sector, taking into account the relevant EU regulations and corresponding conformity assessment procedures, ISO 13485:2016, 21 CFR Part 820 (FDA) and the Medical Device Single Audit Program (MDSAP)
- Shaping the design control process: Development phases (design and development plan), transfer to production (design transfer), up to series approval for the product
- Documentation requirements (design history file) for the individual stages (specification and requirements specification phase, design verification, design validation, design reviews)
- Effectively performing risk analyses as a significant input into the design control process; developing a product test plan for verifying the design
- Requirements for design validation: Incorporating the requirements of EN 62366-1 into the development and risk management process
- Clinical evaluation within the context of development processes (incorporating the evaluation into the development phases)
- Change management in development processes
Target group / seminar duration and certificate
This seminar is suitable for development teams and product managers, as well as staff who assess development processes, such as internal auditors, quality management staff.
The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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