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Is everything in the medical device industry really just a matter of risk management?

The packed room demonstrated just how important the topic is. Following three symposia that had examined clinical evaluation and technical documentation as a whole, the next logical step was to focus on risk management under the MDR – not as an isolated specialist field, but as an overarching issue.

A Focus on Risk Management in Practice: Insights, Challenges and Future Prospects: Findings from the 4th Medical Devices Symposium in Stuttgart!

The symposium sent a clear message: risk management is far more than just a formally correct file. Rather, it determines safety, design, future viability and product liability. Leading figures from the fields of law, consultancy, development and standardisation discussed the interfaces between legal requirements, practical implementation and technological challenges. The focus was on how risk management can evolve from a mere ‘paper exercise’ into an active responsibility, and what impetus the MDR and current standards provide for day-to-day work.

• Legal perspective: Risks are a reality: Dr Volker Lücker, a specialist in medical law, opened the symposium with a incisive analysis of risk management under the MDR. Using real-life legal cases, he demonstrated convincingly how effective risk management can also provide legal certainty in practice.
• Methodology versus routine: What risk analyses must achieve: Elena Kortemeyer, Senior Consultant for Medical Devices at TentaConsult, addressed the discrepancy between established routines and methodologically sound risk analyses. Her presentation made it clear that many test plans and risk assessments are based on habit rather than systematic methodology – a finding that critically examines current practice without pointing the finger. Feedback from participants confirmed its relevance: enlightening and practical.
• Interface coordination: Integration rather than parallel worlds: Florian Tolkmitt, Managing Director at Pro-Liance Global Solutions, highlighted the fact that clinical evaluation, risk management and post-market surveillance are often implemented in isolation. However, the MDR requires an integrated system. Tolkmitt demonstrated in practical terms how interface coordination can be successful and what risks arise when these aspects are dealt with in isolation.
• Standardisation and the future: Outlook on ISO 14971 and AI: Michael Asmalsky, BPO Risk Management at Philips Medical Systems Böblingen and member of the ISO TC 210 JWG1 standards committee, reflected on 25 years of risk management practice. He provided rare insights into upcoming standardisation activities relating to ISO 14971 – from AI and combination products to refining the risk-benefit concept.
• Digitalisation: Opportunities and pitfalls of modern systems: Karl Johan Larsson, Managing Director and co-founder of Aligned AG, posed the critical question: When does a digital risk management system truly improve the process, and when does it lead to unnecessary complexity? Using specific criteria, participants were able to better assess the actual added value of digital solutions.

Conversations that shaped the day!

The symposium stood out from traditional conferences thanks to its lively discussions and interactions. Although participants were initially reserved, an open atmosphere quickly developed, encouraging group work and the exchange of ideas. The workshops, which focused on active participation and personal experiences, were particularly well received.
Anja Heinrich moderated the event and the discussion round in the World Café, ensuring a clear thread ran through the various topics within the overall structure and creating space for exchange.
The repeated participation and ongoing discussions show that a lasting community has formed, one that extends beyond the single event.
“It was not just the processes that were linked by risk management, but the participants themselves,” said Anja Heinrich.

About the Medical Devices Symposium:

The Medical Devices Symposium organised by Alphatopics GmbH is specifically aimed at specialists and managers in the fields of regulatory affairs, quality management, development, production, clinical evaluation and post-market surveillance. The event format combines in-depth specialist presentations, interactive workshop elements and moderated discussion sessions, thereby offering a practical platform for in-depth examination of the current challenges and requirements of the MDR.

About TentaConsult Pharma & Med GmbH:

TentaConsult Pharma & Med GmbH, with offices in Münster and Martinsried, advises life sciences companies on regulatory, quality-related and strategic issues. Its range of services covers regulatory affairs, quality management, vigilance, and support for medicinal products, medical devices, combination products, food supplements and cosmetics throughout the entire product lifecycle.
As part of the Tentamus Group, TentaConsult supports manufacturers from the early development phase through to post-market surveillance. The aim is to provide support on regulatory requirements in a technically precise and economically sound manner, with a focus on practical implementation.