Dr Nisha Vempalle
Dr Nisha Vempalle is a MedTech global regulatory affairs expert specialising in medical devices, in vitro diagnostics and healthcare products compliance. With extensive experience in the EU Medical Device Regulation, the EU In Vitro Diagnostic Regulation and global regulatory frameworks, Nisha has worked closely with Notified Bodies, manufacturers and industry stakeholders to ensure seamless market access and compliance. As the Vice President of Medical Device Regulatory Affairs at RegTrac, Nisha brings deep industry insights into certification strategies for device products, clinical, post-market surveillance and quality management systems.
JournalEssential steps for a successful notified body application in medical devices and in vitro diagnostic products
Navigating the notified body (NB) application process is a critical step for manufacturers seeking CE certification for medical devices under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). A well-prepared application can significantly streamline the approval process, reduce delays and ensure compliance with regulatory requirements.