One of the most integral parts of getting regulatory approval in the European Union (EU) is a Clinical Evaluation Report (CER) that demonstrates the safety, performance, and efficacy of your device. What is a CER? CER is a report of the assessment and analysis of a medical device’s clinical data which is typically collected to…
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For the manufacturers trying to figure out ways to place their medical devices in the EU market, classifying their devices based on their intended purpose should always be the first step. As per the EU regulations, the classification is based on the risks involved in the device. It is very important to classify your device…
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Manufacturers must obtain CE marking for the products they want to sell in the European Union (EU). When a product is CE marked, it means that the product is assessed by the manufacturer and found to comply with EU safety, health, and environmental protection laws. This is a legal requirement for the products that are…
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Ever wondered if the product that you are using is safe? Ever wondered how is the safety assured? Ever wondered where do all the complaints and feedback go? A simple answer to all these is a Clinical Evaluation Report. A Clinical Evaluation Report (CER) documents the clinical data of a medical device and helps in…
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Applying for a CE Marking or have one already? In both the cases, CER would be created or updated per MEDDEV 2.7/1 Revision 4 (June 2016). Non compliance to this new revision of the MEDDEV has resulted in difficulty in getting a CE or the CE of an existing product going on hold. Common pitfalls…
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Background
Mr. Amit is a Biomedical Engineer with a strong background in medical device technology. With over 10 years of overall experience where 6 years were spent by Amit in core medical device troubleshooting and compliance, Amit is able to adopt a very pragmatic approach when helping Clients with testing and compliance issues. Amit is a dedicated professional with attention to details. He has helped successfully navigate many Clients through various stages of regulatory approvals.
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Background
An executive with 15+ years of global, medical and research experience. Demonstrated successes through NIH grant acquisition, board certification, launch campaigns, and executive leadership. Proven industry experience across multiple therapeutic areas (Oncology, Psychiatry, Neurology, etc): Medical Affairs (MA) operations – Medical Education & Writing – Clinical research (P1-4) – Regulatory Affairs – Strategy – leadership –organizational development. Medical Affairs management experience has continually been enhanced from developing new departments to assisting well-established ones for companies with annual revenues of $10M to multi-billion. A natural leader that leverages innate and trained communication skills to effectively coach staff, build talent, develop robust teams, minimize conflict, and drive projects to successful completion with a sense of purpose and attention to detail.
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Background
Mr. Vivek Goyal is an IIT Electrical Engineering and Stanford GSB alumni. He is highly passionate about creating successful businesses, helping companies optimally position themselves and their value proposition, and solving various complex technological problems through advanced software methodologies.
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Background
Ms. Parul is a Biomedical Engineer by profession with more than 15 years of medical device and IVD experience. Parul is a Certified Quality Auditor (CQA) by American Society for Quality (ASQ), RAC certified by RAPS, a trusted thought leader and a decision maker for regulatory strategy, product testing, design controls, risk management, supplier control, quality assurance, regulatory compliance, clinical evaluations, and post-market controls. With a Masters in Bioengineering from UIC, Chicago, she is passionate for medical device and IVD development and has served as the Regulatory and Quality Director for several medical device companies across the world.
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