Practical. Clear. Directly applicable.
Trainings & Seminars
Regulatory Requirements are complex – and they change constantly. Our training programs provide the exact knowledge you really need: without unnecessary theory, with direct relevance to your products and processes.
OUR FORMATS
Two formats – depending on your needs
Workshops
For companies that want to address specific regulatory questions or develop their team in a targeted manner. Content is precisely tailored to your products, processes, and roles.
- Your questions are at the center – no standard program
- Directly applicable knowledge – aligned with your context
- Flexible delivery – from half-day workshops to multi-day support
Seminars & continuing education
For those who want to acquire structured knowledge with a recognized qualification – for personal development or formal continuing education.
- Open seminars with a standardized framework
- Certified qualification with recognized credentials
- Delivered in cooperation with TÜV Rheinland Akademie – for the highest professional and structural quality
What we cover
Topic Areas
Quality Management & QM Systems · MDR/IVDR requirements · Technical Documentation · Post-Market Surveillance · Clinical Evaluation · Performance Evaluation · Risk management · Change Management · Supplier Management · Software & digital Medical Devices including AI · National & international regulations · International approvals · Internal & external audits · Process Validation · statistics · North American approvals
Seminars
Our seminars
Our public seminars for the medical devices industry are organised in collaboration with TÜV Rheinland Academy – designed and delivered by the subject matter experts at regular services. You can find an overview of our joint seminars here.
- Auditor in der Medizinprodukteindustrie
- Auslagerung von Prozessen in der Medizinprodukteindustrie
- CAPA & Co für Hersteller von Medizinprodukten
- Der Weg zur CE-Kennzeichnung: Strategien und Best Practices für Medizinprodukte in Europa
- Design und Entwicklung von Medizinprodukten
- Die neue europäische Verordnung über Medizinprodukte (MDR)
- Keine Angst vor meldepflichtigen Ereignissen bei Medizinprodukten
- Klinische Bewertung von Medizinprodukten
- MDSAP-Medical Device Single Audit Program
- Post-Market Surveillance und Post-Market Clinical Follow-up von Medizinprodukten
- QM-Beauftragte:r (QMB) für Medizinproduktehersteller gemäß EN ISO 13485
- Qualitätsmanagementsystem gemäß 21 CFR 820 (QSR-USA)
- Qualitätsmanagementsysteme in der Medizinprodukteindustrie nach ISO 13485
- Quality Management System according to EN ISO 13485
- Regulatorische Anforderungen an Medizinprodukte
- Regulatory Writing: Professionelle Dokumentation für Medizinprodukte
- Risikomanagement nach ISO 14971 / EN ISO 14971
- Statistische Methoden in der Medizinprodukteindustrie
- Technische Dokumentation für Medizinprodukte gemäß MDR
- Testmethodenvalidierung in der Medizinprodukteindustrie
- Validierung von Prozessen in der Medizinprodukteindustrie
- Verantwortliche Person nach Art. 15 MDR (PRRC)
- Wirtschaftsakteure gemäß Verordnung (EU) 2017/745 (MDR) und (EU) 2017/746 (IVDR)
- Risikomanagement und Gebrauchstauglichkeit von IVD.
- Der Weg zur CE-Kennzeichnung: Strategien und Best Practices für In-vitro-Diagnostika in Europa.
- Design und Entwicklung von In-vitro-Diagnostika (IVD).
Certified Regulatory Affairs training course, including a university certificate.
Knowledge that holds up in daily practice.
Whether a one-off workshop or structured professional training – we find the right format for your needs together.
Request training with regular servicesOur services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about our training courses & seminars
Our workshops are not off the shelf. Content, examples, and focus areas are tailored to your products, processes, and roles – no standard program. The focus is on direct applicability in your daily work.
For everyone who encounters Regulatory Requirements – from QM representatives and Regulatory Affairs teams to development and production staff to executives who need to understand the bigger picture without being detail specialists. We adapt depth and format to your target audience.
Yes – many of our workshops take place directly within the context of a project. For example, when a team needs targeted training in parallel with an MDR transition, or when audit preparation and knowledge transfer go hand in hand.
Yes. Our open seminars and certified professional training courses are delivered in cooperation with TÜV Rheinland and conclude with a recognized certificate – in some cases even with a university degree. In-house workshops conclude with a certificate of participation.
Whether a one-off workshop or structured professional training – we find the right format for your needs together.