ISO 13485 Quality Management System for Medical Devices
7 min

Navigating Unannounced Audits Regulatory Impact and Auditing Expertise

Discover insights from Umesh Soni, a distinguished Senior Medical Device Auditor with extensive experience in regulatory compliance and auditing.

Date: 18 Dec 2023
umesh soni

Umesh Soni, Lead Medical Device Auditor.

Welcome to a discussion with Umesh Soni, MSRA, MBA, Senior Medical Device Auditor. Umesh is a distinguished professional at the forefront of regulatory compliance, auditing, and unannounced audits performed by notified bodies. With expertise and extensive experience in planning and conducting more than 200+ Unannounced Audits, Umesh Soni looks at the critical differences between FDA and EU auditing, the regulatory impact on industries, and the art of effective auditing. 

Could you introduce yourself and your role in the world of auditing and regulatory compliance? 

Certainly! I'm Umesh Soni and I'm currently leading the Unannounced Audit Program in TÜV SÜD America while supporting the special operations team as a Senior Auditor. I am also a Local Certification Reviewer, Technical File Reviewer, and Lead Auditor for MDSAP, MDR, MDD, ISO 13485, and ISO 9001. I have successfully led various process improvement and six sigma projects in TÜV SÜD. With more than 15 years of healthcare industry experience, I have worked and have expertise in Auditing, Regulatory Compliance, Quality Engineering, Regulatory Affairs, Quality Systems, Product Life Cycle Management, Design Development, Manufacturing Process, Sustenance, Remediation, and Post Market. I possess graduate degrees in MBA in healthcare administration and MS in regulatory affairs.  

Unannounced audits by notified bodies are gaining attention. What's their significance? 

With the MDR, more than before, unannounced audits are a game-changer. They surprise manufacturers and assess their adherence to regulations on any given day. Unlike scheduled audits, unannounced audits provide an accurate snapshot of a manufacturer's compliance status, enabling ongoing adherence and patient safety. With the new regulations, notified bodies are getting stricter on auditing and testing requirements for the manufacturers as well as their suppliers.  

Auditing is a core aspect of your work. Could you share your approach to effective audits? 

Effective audits stem from a holistic approach. As a lead auditor for various auditing schemes such as MDSAP, MDR, MDD, ISO 13485, and ISO 9001, I believe in understanding the auditee's processes thoroughly, fostering open communication, listening to their justification, and providing actionable insights. It's not just about identifying gaps, but also assisting organizations in filling those gaps to improve their systems.  

Comparing FDA and EU auditing – what are the key differences? 

Two gigantic regulatory bodies set out to bolster the globalization of medical devices and the healthcare system while continuing to enable the protection of patients and their safety. From a broader perspective, FDA and EU auditing have distinct differences. While FDA audits emphasize compliance with regulations, EU audits emphasize conformity assessment procedures while also taking into consideration harmonized standards. Understanding these differences is crucial for organizations seeking market access in both regions.  

How does regulatory impact influence industries in the context of auditing? 

Regulatory impact is profound. Changes in regulations, such as the introduction of new directives or regulations like MDR, reshape industries. Organizations must proactively align with these changes for uninterrupted market access and maintain the quality of their products. I know a lot of people state that regulations destroy innovation, but I believe these regulations are helping people by enabling patient safety. Recalls and field actions are examples where regulations are helping manufacturers to act when they find issues in post-market surveillance and monitoring. 

Could you offer advice for professionals navigating the intricacies of auditing and compliance? 

Staying updated is non-negotiable. Regulatory landscapes evolve, and professionals must stay ahead by attending training, earning relevant certifications, and engaging in knowledge-sharing networks. Effective auditing is about being informed, adaptable, and meticulous. Over the years, I've been deeply involved in performing audits and adherence to strict standards. My focus extends to unannounced audits performed by notified bodies, an important process that keeps manufacturers on their toes to maintain compliance. In one of the seminars, I presented the importance of internal and external unannounced audits which helps the organizations to be on their toes and understand the ongoing issues which are not visible on regular internal/external audits. 

Share a memorable experience from your auditing journey. 

There are many instances both good and bad. I would like to share one memorable instance where we conducted an unannounced audit and found that the company personnel were aware of the issues. Through external audits, they were able to convince the management to provide support for remediating or correcting those problems. One of the quality team members thanked our auditing team for the independently communicated auditing findings to their management team since they confirmed their internal discoveries as well. As an auditor, we should always remember how critical this role is for building a good quality management system for any organization. Witnessing positive change resulting from audits is incredibly rewarding. 

How do you envision the future of regulatory compliance and auditing practices? 

The future is exciting, marked by technological advancements and global harmonization. With digital tools, audits can become more efficient, and data driven. As industries expand internationally, collaboration between regulatory bodies will drive consistent auditing standards. I can see the changes in regulations and advancement in technology will certainly work together to ameliorate patient safety. Artificial intelligence and robotics are going to be game changers for the future world. 

Umesh Soni's insights into unannounced audits, regulatory impact, and auditing strategies shed light on the intricacies of maintaining compliance. His expertise stands as a guiding force for professionals striving for excellence in regulatory adherence and the art of impactful auditing. 

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