I offer freelance services to the medical device industry through this platform, in regulatory writing, digital marketing, medical communications content and a niche consulting service to dental manufacturers around marketing activities such as target audience recognition and engagement strategies, market research, digital marketing content creation (websites, blogs etc).
I also support the European Medical Writers Association (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). You can read my published articles by clicking here.
Feel free to reach out to me at contactus@namnrpro.org
I worked with cardiovascular, orthopedic, software as a medical device and dental devices where I offer freelance services to the medical device industry through this platform, in regulatory writing, digital marketing, medical communications content creation and a niche consulting service to dental manufacturers around marketing activities such as target audience recognition and engagement strategies, market research, digital marketing content creation (websites, blogs etc).
I also support the European Medical Writers Association (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). You can read my published articles by clicking here.
Feel free to reach out to me at contactus@namnrpro.org
What is the main purpose for the project?
What are the gaps in the current communication style?
Does the language truly resonate with the target audience?
What level of medical explanation is required?
Is it visually pleasing?
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 those working in this domain, to better understand what each type of clinical investigation (CI) entails and facilitate with the medical device study designing process.
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This year, the European Society of Cardiology (ESC) Congress kicked off in a hybrid format, both online and on site, in Barcelona, on the 26th of August 2022. Get an overview of all the latest developments in ASCVD, lipid management, and more.
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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 device’s clinical evaluation.
Although there is no official definition of the CDP, one may simply refer to it as an overview of all the clinical investigations that have either been performed, are ongoing, or are planned in the near future, presented in the Clinical Evaluation Plan (CEP) of the medical device under evaluation.
This article is intended to assist medical device manufacturers and medical writers to leverage the CDP as a tool to showcase their clinical evaluation strategy and plan.
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 software development.
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 performance. The clinical evaluation plan describes the process that will be used to evaluate the performance and safety of a medical device, eventually resulting in a clinical evaluation report. The PMCF plan describes the procedures to collect post-market clinical data that are presented in the PMCF evaluation report. Finally, the summary of safety and clinical performance presents the relevant clinical evidence related to a medical device to healthcare professionals and patients.
“In my capacity as LS Academy Medical Writing Services Coordinator, I have had the pleasure of working with Namrata over a demanding Marketing MedComms project (2021). Under rather time pressure circumstances, I found Namrata exceptionally organized and focused, with both a depth and breadth of understanding that was both refreshing and rare in equal measure. She met all our expectations, with good planning, precise estimates and timely delivery. I concur that our contracting client hold Namrata’s value in equally high regard. I would welcome the opportunity to work with Namrata again, and if you are seeking a professional in the medical communications field then I would fully recommend engaging with her.”
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Monday-Friday: 9:00 – 18:00
Saturday-Sunday: 11:00 – 17:00