sterilization of dental medical instruments
Dental tools
Balloon angioplasty procedure
Female nurse doing sterilization of dental medical instruments in autoclave. Sterilization department at dental clinic

Your DEVICE is meant to improve LIVES.
WE make sure everybody understands HOW.

NamNR Pro provides MedComms and Regulatory writing services to the medicaldevice industry from professionals who are also clinicians.

Dental tools

Your DEVICE is meant to improve LIVES.
WE make sure everybody understands HOW.

NamNR Pro provides MedComms and Regulatory writing services to the medicaldevice industry from professionals who are also clinicians.

Balloon angioplasty procedure

Your DEVICE is meant to improve LIVES.
WE make sure everybody understands HOW.

NamNR Pro provides MedComms and Regulatory writing services to the medicaldevice industry from professionals who are also clinicians.

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Let the Doc write your docs
WHO AM I?
Hi! I’m Dr. Namrata, an experienced dental surgeon as well as a clinical and regulatory consultant for the MedTech sector with expertise in EU regulatory strategy, document creation and submissions for the medical device industry.

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

WHO AM I?
Hi! I’m Dr. Namrata, an experienced dental surgeon as well as a clinical and regulatory consultant for the MedTech sector with expertise in EU regulatory strategy, document creation and submissions for the medical device industry.

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

My Clients
MY SERVICES
Proofreading
Regulatory writing
Regulatory writing for EU MDR compliance, including clinical evaluation plans and reports, clinical investigation protocols, SSCPs, Investigator brochures, Informed consent forms and more
Digital
Digital marketing
Digital marketing consultation (end user assessment), market research and marketing content copywriting (medical devices)
Medical copywriting
Medical copywriting
Medical copywriting for company websites and blogs. As well as proof-reading and editing services for scientific/academic manuscripts in English.
4 (Demo)
Niche service
Niche service for dentistry related marketing content (consultation services for dental device marketing strategies, event planning, content copywriting, website content upgrades to suit end user needs).
The NamNR Pro Method
We start with 5 main questions:
1

What is the main purpose for the project? 

2

What are the gaps in the current communication style? 

3

Does the language truly resonate with the target audience? 

4

What level of medical explanation is required?

5

Is it visually pleasing? 

Our whole process involves 5 steps
Step 1:
We discuss with our client what their vision is for the given project. What do they want to achieve?
1 (Demo)
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Step 2:
We review the current status of information (if present) and identify gaps. If content needs to be written from scratch, we start with a thorough market research.
Step 3:
We start designing the flow of the content and offer our clients a “Suggested flow” document – a crisp yet effective outline of the main sections with a brief description on the purpose of each.
4 (Demo)
9 (Demo)
Step 4:
Once the flow is finalized, the writing begins. Each section is approached individually and shared with the client for feedback. We appreciate our client’s involvement and ask for their input throughout the process rather than just at the end.
Step 5:
The final draft is delivered on time and as per the client’s expectations (if not better!)
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My Portfolio
Medical Devices
Medical Devices

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.

Ready, SET, Go!
Ready, SET, Go!

AH Plus Bioceramic Sealer

ESC 2022 – Daily highlights
ESC 2022 – Daily highlights

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.

Useful Resources – Orthofix
Useful Resources – Orthofix

Useful Resources

The clinical development plan
The clinical development plan

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.

Editorial
Editorial

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.

Medical Devices – Mentorship
Medical Devices – Mentorship

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 the newly implemented Medical Device Regulation (MDR). This article, by Diana Nogueira, helps introduce the essential updates done to ISO 14155 from its previous version and how it may facilitate manufacturers to implement the requirements for clinical investigations for medical devices.

New documents required by the medical device regulation
New documents required by the medical device regulation

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.

WHAT MY CLIENTS SAY
Stamatina
Dr. Stamatina Tzanoulinou
University of Lausanne (UNIL)
Senior Researcher
Dr. Upadhyay has valuable expertise in her field, and is wonderful to work with. Her persistence and forward-thinking are key qualities of her personality that make Dr. Upadhyay an insightful and successful professional. She is always positive, regardless of the difficulty of the task at hand. I had the pleasure to be a colleague of Dr. Upadhyay and I can say that she is a really motivated and dedicated professional, always aiming to deliver to the best of her abilities.
laura
Laura C Collada Ali
LS Academy Medical Writing Services Coordinator

“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.”

Let’s connect
Feel free to suggest your preferred date and time and let’s have a call.

    Contact Me

    1400, Yverdon les bains, Switzerland
    +41 79 967 78 40
    contactus@namnrpro.org

    Working Hours

    Monday-Friday: 9:00 – 18:00
    Saturday-Sunday: 11:00 – 17:00