Summary

“85% of the medical devices in India are imported. There is now a strong focus on developing internally but also make healthcare more accessible to the masses.”

In this Let’s Talk Risk! conversation, Naveen Agarwal engages with Rajesh Kathuria, a seasoned quality executive, to discuss the rapid growth of the MedTech industry in India and the accompanying regulatory changes. They explore the importance of quality standards, particularly ISO 13485, and how these standards are essential for both domestic and international markets. Rajesh shares insights on the evolving expectations of quality in the industry, the opportunities for quality regulatory professionals, and the importance of continuous learning and collaboration in achieving career growth. The conversation emphasizes the need for a cultural shift in quality assurance roles, moving from a policing mentality to becoming enablers within organizations.

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

Chapters

00:00 Introducing Rajesh Kathuria

03:15 Growth of the MedTech Industry in India

07:55 ISO 13485 Based Regulatory Framework

09:15 How High Expectations Drive Product Quality

12:30 Going Beyond ISO 13485 Compliance to Product Quality

16:07 Making a Commitment to Quality and Career Growth

22:30 Regional and Cultural Differences in Quality Expectations

25:05 Final Thoughts and Advice for QA/RA Professionals

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Suggested links:

LTR: Tips for making customer focused decisions.

LTR: Communicate to collaborate, not to impose opinions.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* The MedTech industry in India is projected to grow significantly by 2030.

* Quality expectations are rising due to increased access to global products.

* Regulatory changes are aligning Indian standards with global norms.

* Quality assurance professionals must adapt to new challenges and opportunities.

* Continuous learning and application of quality tools are essential for career growth.

* Cultural differences impact quality expectations across regions.

* Collaboration between quality and other departments is crucial for success.

* Benchmarking against global standards can drive improvement in quality.

* Quality should be viewed as an enabler rather than a policing function.

* Networking with experienced professionals can accelerate learning and growth.

Keywords

MedTech, India, quality standards, regulatory changes, healthcare, ISO 13485, career growth, quality assurance, Southeast Asia, healthcare access

About Rajesh Kathuria

Rajesh Kathuria is currently the Owner and Director at KMS Solutions, B.V, providing strategic consulting services in Quality and Regulatory for medical device companies. He is a seasoned leader with over 20 years of industry experience in senior leadership positions. He holds a Bachelors degree in Mechanical Engineering and Graduate degree in Management with specialization in International Marketing and Finance. He is also a certified ISO 13485 lead auditor and has extensive experience of auditing/working in various geographies and different global regulations.

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.

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