Dr.Ambika Choudari on LinkedIn
In a world where medical devices are transforming healthcare and saving lives daily, ensuring regulatory compliance is crucial to keep these innovations accessible to those who need them most!
A bit late in sharing this, but I’m thrilled to share that I had the amazing opportunity to lead a project at BioElectronics Corporation focused on the development of a Standard Operating Procedure (SOP) for Unique Device Identification (UDI), a critical piece in transitioning our Class IIa medical devices from MDD (Medical Devices Directive) to MDR (Medical Devices Regulation) in the EU.
This transition marks a critical shift in EU regulations, with MDR introducing more stringent requirements for medical devices to enhance transparency, traceability, and patient safety. While our devices currently hold "legacy device" status under MDD until 2028, the UDI SOP ensures we are prepared for future MDR certification, ensuring that our life-enhancing products continue to reach patients worldwide post-2028.
Project Highlights:
•Developed a robust UDI framework, covering key components like UDI-DI, UDI-PI, and EUDAMED integration.
•Aligned with MDR requirements, ensuring our QMS and technical documents are future-ready for Notified Body review
•Set the company on a path for uninterrupted market access beyond 2028, safeguarding patient care globally.
It’s been an incredible experience to contribute to something so impactful and essential for the future of healthcare. I’m looking forward to more opportunities where innovation meets compliance!
Also, I would like to thank Zoya Atiq for her immense support and guidance.
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James M.Barrie
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