Namrata Upadhyay

Dr Namrata Upadhyay is a dental surgeon and an experienced clinical and regulatory consultant with expertise in EU regulatory strategy, document creation and submissions for the medical device industry. Currently employed, part-time, as a Senior Product Manager at Lumendo AG, Switzerland, she also offers freelance services to the medical device industry through her platform NamNR Pro (https://namnrpro.org/) in regulatory writing, digital marketing, medical communications content creation and a niche consulting service to dental manufacturers. Namrata supports EMWA as the Section editor of Medical Writing Journal (medical devices section), Chair of the Expert Seminar Series (ESS - medical devices) and is a member of the medical device special interest group (MD SIG). She is responsible for soliciting section content and is always on the look out for professionals to contribute relevant, technically useful articles, to assist medical writers along their professional journeys. 

www.linkedin.com/in/dr-namrata-upadhyay-574a94174

                                                      https://namnrpro.org/

                                                      contactus@namnrpro.org

Contributions

The clinical development plan - Volume 31, Issue 2

The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…

Editorial - Volume 31, Issue 2

Medical devices are at the core of healthcare forming a large share of the global healthcare market. With consistent advances in technology, MedTech is enhancing our lives more so now than a few decades ago owing to accelerated digitisation and…

Medical Devices - Volume 30, Issue 3

Annex I of ISO 14155:2020 (International Organization for Standardization) helps define the various stages of clinical investigations for medical devices as well as the types of study designs. The following flowchart summarises Annex I, to assist…

Medical Devices - Volume 30, Issue 2

Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…

New documents required by the medical device regulation - Volume 29, Issue 3

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…