A medical device manufacturer approached Elexes with a very unique medical device. While the product had a lot of advantages over any other treatment option in the target clinical area, the manufacturer was unsure of how to get the product to the market in the least burdensome accelerated manner. Elexes reviewed the product and since…
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All the medical device manufacturers that intend to place their devices in the US should label their devices considering the Unique Device Identifier (UDI) requirements. UDI is a unique numeric or alphanumeric code that facilitates the identification, traceability, and tracking of medical devices during their distribution and use. Recently, the FDA has suggested forms and contents of…
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The purpose of conducting an Internal Audit is to evaluate the efficiency of an organization in terms of quality processes, risk management, and overall business practices with respect to applicable standards and regulations. An internal audit is a means of identifying any shortcomings in the quality processes in order to plan actions to correct and…
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Alert Call for Medical Device Manufacturers who are looking to place the Spinal Implantable or any other type of Medical Devices in the Australian market (via the TGA approval or notification process). It is time for you to revisit the regulations and brainstorm on your next steps. TGA reclassified a number of medical devices to align its…
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Are you one of the many Medical Device Manufacturers who is struggling to figure out the potential benefits of the Medical Device Single Audit Program (MDSAP)? Well, here we are, to assist you. Many Medical Devices Manufacturers all over the world have various misconceptions when it comes to the cost and duration of the MDSAP Audits…
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Biological evaluation of medical devices – Part 12: Sample preparation and reference materials We all are aware that the 2021 version of the ISO 10993-12 has been released and there is anxiety amongst the medical device professionals and manufacturers regarding the new additions in the amendment. Since this standard has repealed the 2012 version of…
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India is considered one of the leading worldwide medical device markets. Being in this position, India has made a significant change towards its device classification which made the regulatory pathways and requirements more clear. CDSCO revised the medical device classification as per the new risk-based approach under the provision of medical device rule 2017. Applicability of reclassification on device…
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More than 190,000 distinct medical devices are regulated by the FDA. Data from the years 2017 & 2018 indicates that about 3000, on average, low and moderate-risk medical devices received FDA’s 510(k) clearance. This accounts for 80% of total medical devices approved or cleared. The 510(k) clearance pathway was first framed in the year 1976.…
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Have you: In all the above scenarios, you need to ascertain whether your medical device is exempt, i.e., an FDA review (510(k)) is not required and if the device does meet the exemption criteria. Let us walk you through this information: What type of devices are exempted? All devices are classified in accordance with the…
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“Any sufficiently advanced technology is indistinguishable from magic.” Arthur C. Clarke’s Third Law, Profiles of the Future, 1973. Are you aware that in today’s world you can visualize the opening and closing of a patient’s mitral valve from a 3D perspective? Do you think this is magic? There is an explosion of technology in imaging…
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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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