Summary

“A major change proposed in the draft of ISO 10993-1 revision is the focus on foreseeable misuse and effect of cumulative device use for biological safety. ”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Priyanka Murawala, an expert in biological evaluation of medical devices. They discuss the latest updates on ISO 10993-1, the differences in regulatory approaches between the EU and the US, challenges faced in biological evaluation, significant recalls related to biocompatibility, and best practices for ensuring safety in medical devices. The conversation emphasizes the importance of risk assessment and the need for effective communication in the medical device industry.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:15 Introducing Priyanka Murawala

02:16 Key Focus in Revised ISO 10993: Foreseeable Misuse and Cumulative Use

04:320 Comparing EU and US Regulatory Approaches to Biological Evaluation

07:27 Challenges in Meeting Regulatory Expectations for Biological Evaluation

11:49 Learning from Device Recalls

19:37 Considering Risk of Residual Processing Agents in Manufacturing

22:45 Announcements, Key Takeaways and Closing Comments

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Suggested links:

LTR: Focus on risk, not just testing for biocompatibility of medical devices.

Nelson Labs: ISO 10993-1 Key update on the new revision of this critical standard

ACHIEVE: FMEA Workshop.

Key Takeaways

* ISO 10993-1 is being updated to focus on foreseeable misuse.

* The EU and FDA have different approaches to biocompatibility evaluation.

* Regulatory bodies often require extensive testing even for minor design changes.

* Biocompatibility recalls highlight the importance of thorough risk assessment.

* Involving biocompatibility experts early can improve safety outcomes.

* Quality management systems should comply with ISO 13485 standards.

* Post-market surveillance is crucial for learning from device performance.

* Effective communication of risks is essential in medical device labeling.

* Anticipating risks early in the design phase can prevent future issues.

Keywords

Biocompatibility, risk assessment, foreseeable misuse, ISO 10993, medical devices, regulatory differences, FDA, EU, biological evaluation, recalls, best practices

About Priyanka Murawala

Priyanka Murawala a seasoned regulatory affairs expert and founder of Eunoia Compliance, where she helps medical device companies navigate FDA and EU MDR requirements with a focus on biocompatibility and quality systems. Priyanka holds a PhD in Physical and Materials Chemistry and has conducted postdoctoral research in regenerative medicine at TU Dresden. With deep expertise in ISO 10993 and ISO 13485, and a strong background in biomaterials and nanotechnology, she brings a unique blend of scientific insight and regulatory strategy to every project.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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