Regulatory requirements for medical devices and in vitro diagnostic devices do not apply solely to regulatory affairs and quality management. Development, product management, clinical evaluation, and senior management also make decisions with regulatory implications. A lack of a shared understanding can lead to inefficiencies, incomplete documentation, and avoidable rework. External expertise alone is therefore generally insufficient. Regulatory expertise should also be embedded within the company itself.
What is In-House Training?
In-house training provides teams with practical regulatory expertise so they can properly understand and apply relevant requirements within their respective areas of responsibility. The content, depth, and format are tailored to the product, the level of maturity, and the specific tasks of the participants. The training is suitable both for onboarding new employees and teams and for targeted in-depth exploration of individual topics.
Result
Through a specialized training program, teams develop a shared understanding of regulatory requirements and learn to interpret and apply relevant requirements in their daily work in a professionally sound manner. The following aspects are addressed in particular:
- Fundamentals and Structure of the MDR and IVDR
- Intended Use, Qualification, and Classification
- Conformity Assessment, Notified Bodies, and CE Marking
- Quality Management According to ISO 13485 and Related Processes
- Technical Documentation, Risk Management, and Documentation
- Software, AI, Cybersecurity, and Interfaces with Other Regulatory Areas
- Clinical Evaluation, Performance Evaluation, and Post-Market Requirements
- Roles, Responsibilities, and Interfaces Within the Organization
Procedure
- Determine needs
Coordinate the product, life cycle phase, target market, prior knowledge, learning objectives, and desired scope of the training. - Agree on content
Coordinate topics, key areas, and practical examples with an eye toward the target audience, learning objectives, and desired product relevance. - Select the format
Determine the format, dates, duration, participant group, and organizational framework. - Training and practical application
Practical delivery of content with opportunities for questions and discussions, as well as the provision of training materials and technical guidance for internal use.
The training’s content, key topics, and practical examples can be tailored to specific issues, products, and learning objectives to the extent agreed upon. The focus is on knowledge transfer and practical application.
Benefits
- A shared understanding of regulatory requirements across departmental boundaries
- More informed decisions in development and project work
- Potential for fewer follow-up questions, rework, and coordination loops
- Practical content drawn from the participants’ own product and project contexts
- Documented transfer of relevant regulatory knowledge
- Less reliance on external support
- Tailored to the target audience, prior knowledge, and available time
