Regulation

Interview on PFAS substitutes: ‘None of the identified materials proved to be technically feasible.’

With the help of AI, the Thinktank Industrial Resource Strategies set out to find PFAS alternatives that are suitable for medical technology. Inside Industry interviewed Thinktank Managing Director Christian Kühne about the sobering results and possible consequences.

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From development to product launch

From development to product launch, we guide you through the complex world of regulatory affairs. Find out how our comprehensive quality and risk management and our expertise in standard-compliant documentation ensure your success. Find out more!

IP due diligence check

In classic M&A agreements, for example when acquiring a company, industrial property rights (patents, utility models, trade marks and/or designs) are regularly part of the subject matter of the agreement. The same applies to licence agreements.

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‘Conformity to standards means that everything relating to the process is documented’

According to the Federal Office for Drugs and Medical Devices, risk reports have multiplied, often due to ‘inadequate manufacturing processes’. It’s important to make sure that processes are validated to avoid errors. We spoke about this with expert Robert Schreiner from Novoplast Schlauchtechnik.

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We answer your questions about regulatory affairs!

Have you defined the intended use of your medical device correctly? Is the device clarification unclear? Is your regulatory strategy adequate? Have you started compiling your technical file? Confused by too many questions?! We are here to give you the answers. Book a free consultation slot now!

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MIK - MDR- & IVDR-Competence Centre

As a competence center, MIK offers consulting and development capacities and is oriented towards the needs and requirements of the industry. The holistic approach of MIK accompanies you on the way from the idea to the certification of your innovative products.

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Experts of novineon CRO

Meet our experts at booth 1-316 and benefit from their extensive know-how on IVDR, international approvals & FDA and clinical trials. We look forward to sharing our experience with you.

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Risk-based system architecture

In its Appendix I the MDR requires the development of safe, effective medical products. During development, there's a risk of not specifying the product correctly or specifying it to an exaggerated extent. Our systematic approach to a risk-based system architecture provides a remedy and saves costs.

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New Requirements for the Toxicological Risk Assessment of Extractable and Leachable Components

As part of chemical characterization, our experts are ready to assist you with the toxicological assessment of extractable and leachable components following the latest requirements of ISO 10993-17:2023.

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Consulting for Medical Devices

Ready for the MDR? We support you with documentation and assessment for your medical devices, covering biocompatibility, sterilization, reprocessing, packaging, and shelf life.

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