Having built up experience within the medical device industry and a leading Notified Body, Annapoorna has the dual perspective that may be utilized to help your company establish and maintain an effective quality management system.
Learn MoreWith extensive experience as a QA/RA professional, a Notified Body technical documentation assessor, and a contributor to Team NB's Best Practice Guidance for MDR, Annapoorna knows what constitutes a 'good' Technical Documentation File. You can leverage this inside expertise to ensure your submissions are impeccable and your review process is seamless.
Learn MoreNavigating regulatory approval can be challenging, and critical details are easily missed. Having worked directly within industry and a Notified Body, Annapoorna is well aware of exactly where manufacturers typically struggle when building quality systems or technical files. You can collaborate with Annapoorna to bridge those gaps and upskill your team.
Learn MoreHit a roadblock with your device development or regulatory submission? Access AR Med’s flexible, ad hoc consulting to get the specialized expert guidance you need, exactly when you need it.
Learn MoreThe initial stage of a Notified Body assessment requires reviewing a product's regulatory classification, intended purpose, and indications for use. Because these elements dictate the scope of the entire evaluation, securing them early is critical. Doing so prevents downstream delays and eliminates the need for reactive revisions to your clinical claims or intended purpose. To solidify these critical components prior to filing, consult with Annapoorna to leverage her specialized experience and streamline the approval process.
Receive the premium, tailored QA/RA solutions your business requires, backed by the dedicated support you deserve. Don't see exactly what you're looking for? Reach out to AR Med to discuss your unique project requirements.
Annapoorna is a medical device expert who has worked in the medical device world starting off as a Quality Engineer at a medical device firm in the USA. She progressed through various roles in multiple countries, leading to being Head of Quality Management at a Class III coronary and other implantable devices establishment in Germany. After several years in the industry, Annapoorna moved to the so-called 'other side of the table' and joined a leading EU Notified Body as a Lead Auditor and Technical Documentation Assessor. The experience of being a regulator and regulated professional enables Annapoorna to face projects and challenges with a unique, practical, compliant and effective approach. Annapoorna is a collaborative professional who thrives in multicultural, cross-functional team environments.
"Honored to have the opportunity to write recommendations for Annapoorna Rajan. Her knowledge of the industry has made her a mature sparring partner for the medical device industry in general, for both QMS and also specific product certifications. Her knowledge of medical devices in the cardiovascular world is clearly demonstrable. She has been able to use this knowledge in a constructive manner during her daily work at DEKRA Certification B.V. Annapoorna has been a mature sparring partner, open for challenges and new innovations. She is easy to work with, and I can strongly recommend her personality and competences for consultancy work in the medical device world."
"Annapoorna is a knowledgeable quality and regulatory professional who strikes the right balance between compliance and pragmatism when handling projects. Her capacity to consider challenges from different perspectives is a strength in the complex field of medical devices. This is supported by Annapoorna's strong expertise in technical documentation, and experience in auditing against relevant medical device standards.”
“I see you as a dependable and highly knowledgeable project manager who brings clarity and structure to complex regulatory work. Your expertise in medical device regulations really comes through in how thoroughly and thoughtfully you approach audits and technical documentation reviews. You have a strong eye for detail while still keeping the bigger picture in mind, which is especially valuable in such a highly regulated environment. You also communicate in a calm and professional way that puts clients at ease. What I appreciate most is your ability to combine technical depth with a pragmatic mindset. Overall, you're someone I'd trust to handle complex compliance challenges with confidence and integrity.”
“Annapoorna is not only well versed in critical areas of Quality Management and Auditing she also brings a can do collaborative approach to her day to day task with a unique ability to inspire those around her to perform at their best.”
“Annapoorna is a very strong and detailed working person. She improved our Quality System in a clear and efficient way. Her working style is precise and as such she could lead her department in an efficient and motivating way. Working together with other departments was always fruitful. With her great passion for her job, her advices to the General Management of the company has been always analytic and in the best way for the company, customers and respected always the legal requirements. She has a special talent to turn problems into solutions and it has been a gret pleassure to work with her.”
“Annapoorna is a highly qualified, knowledgeable, and brilliant professional in the field of quality assurance and regulatory strategy. She knows how to work with both established companies and medical device startups. Her ability to energize & motivate the team and instill the quality culture in the company is remarkable. She works well with all team members and with the management. I have seen her sweep through complicated issues and regulatory hurdles with speed, perfection and a gentility that puts her at the top of the heap. Annapoorna is also a pleasure to work with and I highly recommend her.”
Additional Professional References
More professional recommendations and references can be found on
Annapoorna Rajan's LinkedIn profile
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Email: annapoorna_rajan@outlook.com
Lüneburg, Germany