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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.
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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 ...
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| 06.10.2026 3 h | 3 h | Details | Details Jetzt buchen | |