In recent times, there has been a growing concern related to the safety of breast implants. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is one of the major pathologies associated with these implants, especially those are textured The U.S. Food and Drug Administration had warned women since 2011 about the risk associated with the implants…
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EU MDD to MDR – A major change Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and implemented by the industry for over several decades. The advent of new rules, European Medical Device Regulations (EU MDR), is a major change to…
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The new Medical Device Regulation has been postponed by a year, however, the regulation is still coming and all medical device companies will be eventually expected to comply with it in order to keep the continuity of the sale in Europe. It’s certainly wise for companies to invest the time in understanding the differences between…
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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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Behind every innovation, there are years of hard work, passion, and perseverance. A medical device based on innovation, meticulous planning, and excellent execution goes a long way in changing the lives of many. To protect our innovations we file patents, hire lawyers and get NDAs in place, but sometimes tend to overlook the need of…
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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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The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical field. There are three types of software related to medical devices. SaMD is software which on its own is a device employed for a medical purpose. The International Medical Device Regulators Forum (IMDRF)…
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Learn about the importance of Quality Objectives (QO), how are they important for a medical device company’s Quality Systems, and how to draft accurate Quality Objectives intended to drive improvements, customer satisfaction, and product quality, while being in line with the Quality Policy (QP) of the Organization. What are Quality Objectives? Quality Objectives are a…
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While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never do they want to decelerate the pace at which new technologies are coming to the market. Along these lines is the FDA’s De Novo classification process which is used to classify medical devices…
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There are some important requirements for establishing SE. The flowchart below lays out, at a high level, the decision making process that the FDA employs to come to a decision of SE or NSE (Non Substantially Equivalent). Every person who wants to market a medical device in the United States, be it a Class I,…
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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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