Digital MedTech Roundtable 2026.
- Konferenz
- Virtual Classroom
- 1 Termin verfügbar
- 3 Unterrichtseinheiten
- Teilnahmebescheinigung
- Online durchführbar
Practical forum: Compliance by Design & PFAS Regulation – current challenges in medical technology discussed live!
Competitive medtech companies can no longer afford to take a late, purely auditing approach to compliance. This is where compliance by design comes in: organisation, processes and culture are aligned in such a way that regulatory requirements are integrated into product strategy and development from the outset. Instead of working through checklists at the end of the project, risks are identified early on, requirements are taken into account in parallel and decisions are documented transparently – across all areas involved, such as development, regulatory affairs, quality, purchasing and supplier management.
In this context, the EU Packaging Regulation (PPWR, in force since 11 February 2025) and the PFAS limits applicable from August 2026 will become a key touchstone for effective compliance by design approaches. Without such a process model, PPWR and PFAS requirements often only become apparent during design approval, supplier qualification or the approval process – with serious consequences: redesigns, material and supplier changes, significant cost increases, delays and, in extreme cases, loss of market access.
The Digital MedTech Roundtable shows how compliance by design can serve as an organisational backbone for systematically integrating PPWR, PFAS, REACH and MDR requirements. You will experience how methodological "how" (structures, processes, culture) and regulatory "what" (specific PPWR/PFAS requirements) are brought together: Substance and supply chain analyses, PFAS substitution, recyclability evidence and documentation are not considered in isolation, but are understood as integrated building blocks of a continuous development and approval process – and thus transform from a pure risk into a strategic advantage for manufacturers, distributors and suppliers in medical technology.
Nutzen
- You will understand how compliance by design integrates PPWR, PFAS, REACH and MDR requirements from the outset, thereby shortening time-to-market and reducing costs.
- You will see how the methodological "how" (organisation, processes, culture) is interlinked with the regulatory "what" (PPWR/PFAS) – instead of later, isolated compliance checks.
- You will gain practical insights from the medical technology value chain, including typical pitfalls and proven solutions.
- In breakout rooms, you can explore the topics in greater depth with experts and other professionals from your industry.
- You will use the roundtable for targeted exchange in breakout sessions and build a network with experts and industry colleagues.
Zielgruppe
This event is aimed at:
- Manufacturers, suppliers and service providers of medical devices
- Start-ups and innovators in medical technology
- Employees of notified bodies and authorities
- Healthcare providers and hospital administrators
- Quality assurance and risk management experts
- Environmental and sustainability experts
- Legal and compliance officers
Inhalte
- 2:00 p.m.: Opening
Welcome by TÜV Rheinland Academy and moderation by regular services rs GmbH.
- 2:10 – 2:50 p.m.: Topic 1 – Compliance by Design
Agile development under regulatory requirements. Speaker presents challenges, best practices (Design for Six Sigma, Lean Progress Model), cyber security & digital architecture, and success factors.
Speaker: Bernd Schleimer, Head of Customer Care & Sales Medical by TÜV Rheinland LGA Products GmbH
- 2:50 – 3:00 p.m.: Knowledge check/interaction
Take advantage of this opportunity for a brief interaction to share your opinion and actively participate in the exchange.
- 3:00 – 3:10 p.m.: Short break
- 3:10 – 3:50 p.m.: Topic 2 – PPWR & PFAS Regulation
Packaging as a strategic compliance component. Overview of PPWR (effective date: 11 February 2025), PFAS limits for packaging, practical implications for medical technology manufacturers.
Speaker: Steffen Tümptner; Expert of TÜV Rheinland LGA Products GmbH
- 3:50 p.m. – 4:15 p.m.: Breakout sessions
Use this time for direct exchange with the experts. Ask your questions, discuss current challenges – an opportunity for more intensive dialogue in smaller groups.
- 4:15 – 4:30 p.m.: Conclusion & networking
We will summarise the most important findings and show you concrete next steps: What challenges lie ahead in the coming 12 months? How can you prepare your organisation? You will receive access to the recording and stay connected to our network of experts through feedback and networking.
Hinweise
- For the second and each additional participant from a company, the participation fee is reduced by 50% and amounts to €125 plus VAT for these individuals.
- Following the event, a recording of the digital round table will be available on the after-event website and can be downloaded for four weeks. You also have the option of watching video recordings of individual segments.
- The digital participation format offers you maximum flexibility: you can participate from your workplace or on the go. A stable internet connection and an up-to-date browser are required.
- After the event, you will receive a My-Advice-link for your feedback on the content and format. Your feedback will help us to make future roundtables even more targeted.
- If you have any further questions about the event, technical requirements or registration, please contact christiana.biene@tuv.com.
