Summary

“You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.”

In this Let’s Talk Risk! conversation, Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing clinical literature reviews and signal detection in adverse events. The discussion also highlights the need for effective communication through storyboarding and the proactive approach required in the medical device industry. Dr. Fernandes concludes with key takeaways that inspire risk practitioners to embrace change and work towards better patient outcomes.

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

Chapters

00:13 Introducing Dr. Queenita Fernandes

02:02 Personal Journey and Influences

03:44 Literature Review from a Clinician's Perspective

07:56 Integrate Clinical Perspective with Engineering to Design for Safety

10:04 Working Smart with AI Tools for Reviewing Clinical Literature

16:58 Using Storyboards for Effective Communication

20:50 Embracing AI Tools to Facilitate Collaboration

23:19 Imagining a Validated Real-Time AI System for Clinical Review

25:43 Announcements, Key Takeaways and Closing Comments

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Databases and automation tools for clinical evaluation.

LTR: Understanding the notified body perspective on clinical evaluation.

ACHIEVE: FMEA Workshop.

Key Takeaways

* Think proactive and partner cross-functionally.

* Embrace technology and work smart.

* AI should be viewed as a tool, not a replacement.

* People generally intend to do good things.

* Literature review can be intimidating but manageable.

* Engage healthcare professionals in decision-making.

* Use storyboarding for effective communication.

* Signal detection is crucial in adverse event reporting.

* Collaboration is key in the medical device industry.

* Always put the patient at the center of evaluations.

Keywords

Risk management, healthcare, clinical evaluation, AI in healthcare, adverse events, medical devices, literature review, signal detection, technology in healthcare, collaboration

About Queenita Fernandes

Queenita Fernandes is a physician executive and certified patient safety expert with over 20 years of experience in medical safety, post-market surveillance, and regulatory writing. Her background spans clinical medicine, nutrition, and leadership roles across the MedTech ecosystem.

Queenita is known for her work in proactive PMS, systematic literature reviews, and benefit-risk analysis under EU MDR and FDA frameworks. She brings a unique ability to translate clinical insight into regulatory strategy, improving safety signal detection and patient outcomes.

A frequent speaker at international conferences and webinars, she is a trusted voice on how to strengthen post-market processes through rigor, ethics, and cross-functional collaboration.

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.

FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025:

With the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information and other information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important.

Further;

In addition, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cyber incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyber incidents and exploits may lead to patient harm as a result of clinical hazards, such as delay in diagnoses and/or treatment.

It is important to view FDA’s expectations outlined in this final guidance from the perspective outlined above. Cybersecurity is not an add-on; rather it is now considered to be an essential factor in assessing medical device safety and effectiveness throughout its total product lifecycle.

A risk-based approach is recommended to compile documentation for pre-market review, and continued surveillance and actions in the post-market phase.

🎧Listen to a brief audio summary of this guidance and recommendations QA/RA and Risk professionals can apply in practice.

Thanks for reading! If you liked this post, please share with others.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:

* FDA: Final Guidance for Cybersecurity in Medical Devices, Issued June 27, 2025.

* FDA: Draft Guidance for Cybersecurity in Medical Devices, Issued September 27, 2023.

* FDA: Cybersecurity in Medical Devices Frequently Asked Questions, Website accessed July 01, 2025

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

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

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.

Summary

“The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.”

In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opportunities in bringing innovative medical devices…

Summary

“MedTech in India is poised to generate $50 billion in revenues by 2030.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges faced in regulatory compliance and offers career advice based on his extensive experience in the field. The conversation highlights India's potential to become a significant player in the global MedTech market by 2030.

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

Chapters

00:20 Introducing Sanjay Arudi

01:25 Current State of MedTech in India

03:24 Government Initiatives and Domestic Manufacturing

07:44 How Tariffs Might Impact MedTech Companies

09:12 Regulatory Environment for Medical Devices

14:06 Post-Market Surveillance and Reporting Requirements

19:50 Regulatory Compliance Challenges in India

22:33 Career Insights and Advice from Sanjay

25:31 Announcements, Key Takeaways and Future Outlook

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: An exciting growth opportunity for MedTech in India.

LTR: Navigating the regulatory landscape for SaMD in India.

ACHIEVE: FMEA Workshop.

Key Takeaways

* India's MedTech industry is projected to generate 50 billion by 2030.

* Government initiatives are crucial for expanding healthcare access.

* 80% of medical devices in India are currently imported.

* The CDSCO license facilitates entry into multiple markets.

* Post-market surveillance is becoming increasingly important.

* Regulatory compliance requires collaboration with regulators.

* Transparency in reporting adverse events is essential for patient safety.

* India's healthcare market is rapidly evolving post-COVID.

* Investments in domestic manufacturing are on the rise.

* Career success in regulatory roles requires active contribution and solution-oriented thinking.

Keywords

MedTech, India, healthcare, regulatory environment, government initiatives, post-market surveillance, medical devices, industry growth, career advice, healthcare innovation

About Sanjay Arudi

Sanjay Arudi is the Vice President of Regulatory and Quality at GE Healthcare. He has over 30 years of professional experience in engineering, management and senior leadership roles. His expertise includes product transfers, program management, implementation of Quality & Regulatory requirements across Design, Sourcing, Manufacturing, Install Base & Commercial activities. He has many years of experience in working with global regulators in creating a compliant & friendly manufacturing environment. He holds a Bachelor’s degree in Polymer Science & Technology.

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.

The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments,

Severity Rating has been incorrectly selected for many assays’ false result failure modes.

Additionally, FDA found issues with procedures for CAPA, Nonconformances and Design Controls:

* Criteria for escalating nonconformances to CAPA are not defined clearly

* No process for assessing risk assessment of individual nonconformances

* Severity classification of nonconformances released to the field is not adequately defined

* No criteria for escalating complaints to CAPA based on trend analysis

* CAPA actions are not verified and validated for effectiveness and additional adverse effect(s) on the finished devices

* Inadequate procedures for verification and validation of design changes

🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice.

Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:

* FDA: Warning letter, Beckman Coulter Inc., CMS 678042, March 15, 2024.

* K011920, EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, cleared July 2, 2001.

* K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM, cleared June 14, 2013.

* K221225, Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, cleared November 10, 2022.

* Beckman Coulter: Therapeutic Drug Monitoring Flyer FL-47564.

Summary

“The 2025 conference was held in Amsterdam and it really was an amazing success.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Bijan Elahi, a leading authority in medical device safety risk management. They discuss the recent 2025 International Medical Device Safety Risk Management conference held in Amsterdam, focusing on the evolution of patient-centric safety, the importance of education in the field, and the key themes that emerged from the conference. Bijan shares insights on the future of medical device conferences and the need for collaboration and community support in advancing safety practices.

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

Chapters

00:15 Introducing Bijan Elahi

01:05 2025 International Medical Device Safety Risk Management Conference

04:28 Growing Awareness of Patient Safety in MedTech

07:21 Pre-Conference Education Day: Enhancing Knowledge

10:40 Key Themes from the 2025 Conference

12:51 Recognizing the Role of Physicians in Risk Management

14:00 Looking Ahead: 2026 International Conference Planning

17:19 Live Stream and Recording of Conference Presentations

19:23 Support Needed for 2026 Conference

22:30 Announcements, Key Takeaways and Closing Comments

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Conference Recordings:

Conference recordings are available until Jul 31, 2025 at €99.5.

Suggested links:

LTR: Critical role of medical safety officer in medical devices.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: FMEA Workshop.

Key Takeaways

* The 2025 conference in Amsterdam was a unique gathering of experts.

* Patient safety should be the guiding principle in medical device design.

* Education is crucial for enhancing knowledge in safety risk management.

* AI and machine learning are becoming central topics in medical device safety.

* Collaboration among professionals is essential for advancing safety practices.

Keywords

Medical device, safety risk management, patient safety, international conference, education, AI, collaboration, healthcare, risk assessment, ISO 14971

About Bijan Elahi

Bijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He has trained over 10,000 professionals worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.

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.

Summary

“We still see companies having difficulty in accepting risk management as a tool for better decision making. Risk is often seen as a blocker rather than an enabler.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal and Brett Travaglio discuss the challenges and opportunities in risk management within the medical device industry. Key themes include cultural resistance to risk management, the importance of clear roles and responsibilities, the integration of project management principles, and the evolving role of AI in enhancing risk management practices. The discussion emphasizes the need for training and collaboration among cross-functional teams to effectively navigate the complexities of risk management in a dynamic regulatory environment.

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

Chapters

00:15 Introducing Brette Travaglio

01:10 Organizational Barriers in Risk Management

03:46 Training for Improved Team Collaboration

08:34 Applying Project Management Skills for Excellence in Risk Management

10:39 Improving Basic Understanding of Risk Management

13:09 Navigating the Current Regulatory Chaos

15:42 How AI-Assisted Reviews will Impact FDA Reviews

19:17 Using AI to Prepare Regulatory Submissions

24:12 Handling Device Deficiencies in Clinical Trials

25:32 Using Ambient AI to Improve Healthcare Delivery

26:49 Announcements, Key Takeaways and Closing Comments

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Collaboration that drives innovation, not delays.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: FMEA Workshop.

Key Takeaways

* Cultural resistance is a significant barrier to effective risk management.

* Risk management is often perceived as a tedious exercise.

* Clear roles and responsibilities are crucial for effective risk management.

* Training for collaboration is essential in cross-functional teams.

* Project management principles can enhance risk management practices.

* Understanding risk management standards is vital for compliance.

* Companies should build internal strength to navigate regulatory challenges.

* AI can provide valuable insights for risk management.

* Training is necessary for effective AI integration.

* Collaboration must be a conscious effort, not assumed.

Keywords

Risk management, medical devices, regulatory affairs, AI in healthcare, project management, collaboration, training, quality assurance, risk assessment, industry challenges

About Brette Travaglio

Brette Travaglio is the President and Consultant for Drug, Medical Devices, Biologics and Combination Product Manufacturers at Quality Solutions Now (QSN). She has over 25 years of industry experience at leading organizations with expertise in R&D, quality, regulatory affairs, and process improvement. At QSN, she leads a team to provide hands-on project management and consulting services to drug, medical device, biologics, and combination product manufacturers. QSN’s proprietary process, qsnFLOW™, enables them to quickly deploy highly skilled professionals to tackle challenges with flexibility, scalability, and cost-effectiveness. She holds a Bachelors degree in Aerospace Engineering, and Masters in Business Administration and Industrial Engineering.

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.

Summary

“Communities of practice are more than just knowledge sharing platforms. They serve as engines for standardization and cross-functional alignment across various business units.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ronak Dunung, a rising star in medical device risk management. They discuss Ronak's journey into risk management, the importance of creating a community of practice within organizations, and the challenges and successes associated with fostering collaboration and knowledge sharing. The conversation emphasizes the need for leadership support, measuring success, and building excitement among participants, while also highlighting the unexpected cultural impacts that such communities can have. Ronak shares insights on mentorship opportunities and the importance of continuous learning in the field of risk management.

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

Chapters

00:20 Introducing Ronak Dunung

02:53 Creating a Community of Practice for Risk Management

06:00 Overcoming Challenges in Establishing a Community of Practice

07:23 Securing Leadership Support

11:29 Measuring Success and Engagement

13:41 Gamifying to Increase Engagement and Adoption

19:36 Building Leadership Skills Through Mentoring

24:16 Announcements, Key Takeaways and Closing Comments

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Collaboration that drives innovation, not delays.

LTR: Tips for improving collaboration in risk management.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Creating a community of practice is essential for knowledge sharing.

* Top management must support risk management initiatives.

* Engagement metrics are crucial for measuring community success.

* Building excitement is key to maintaining participation.

* Communities provide opportunities for informal mentorship.

* Cultural impact is a significant outcome of community practices.

* Small, deliberate changes can lead to cultural shifts.

* Communities can pilot new strategies for risk management.

* Recognition and rewards can enhance participation.

* Leadership skills can be developed through community involvement.

Keywords

Risk management, community of practice, leadership support, engagement, mentorship, medical devices, organizational culture, success metrics, continuous learning, collaboration

About Ronak Dunung

Ronak Dunung is a Senior Manager and Process Owner of Risk Management at a leading MedTech. He specializes in creating effective risk management and strategies in compliance with ISO 14971 requirements for medical devices. He has over 15 years of industry experience in both engineering and risk management leadership. He holds a Bachelor’s degree in Biomedical/Medical Engineering.

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.

The EYE-SYNC(R) device uses a modified virtual reality headset, connected to a tablet, to track eye movement in response to visual stimuli for assessment of a concussion. In a recent warning letter, FDA cited the following issue with software risk analysis:

Your Risk Management Procedure, SOP-10011, Rev 002, states that the level of risk is determined by Risk Priority Numbers(RPN) and that the design (b)(4) will use the severity and occurrence rating scales described in the procedure. However, your software (b)(4), RA-10110, Rev 006, does not use RPNs, and the impact and probability scale used to calculate inherent and residual risk are not adequately defined within SOP-10011.

When software risk analysis is not correctly done, it can have a serious impact on design verification and validation. As a result, the device may fail to reliably function during real-world use, leading to serious risk of harm from false negative, false positive and unreliable results.

🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice.

Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.

Note:

The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:

* FDA: Warning letter issued to NeuroSync, Inc., CMS 705489, May 09, 2025.

* DEN170091, EyeBox, Predicate device for EYE-SYNC, granted December 28, 2018.

* K202927, EYE-SYNC 510k clearance, October 2, 2021.

* YouTube: Podcast with Scott Anderson, CCO, SyncThink, 2022.