Medical devices are one of the world’s most traded commodities. The United States stands top in both the export and import of medical devices as per recent statistics. Considering the very nature of medical devices, testing their safety and efficacy becomes crucial as they directly impact the health and lives of mankind. Manufacturers must adhere…
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Quality audits play a fundamental role in the establishment of a company’s Quality Management System (QMS). An audit provides the opportunity for an organization to take corrective actions and address the identified non-conformances to get its processes in line with its intended goals. Regulatory authorities across the globe have mandated manufacturers to undertake initial and…
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A medical device company wanted to get into the Canadian Market to meet the requirements of many of its customers. However, they were unsure of how to begin this journey and what should be done to achieve authorization to sell legally within Canada. Primary objectives: The primary objectives of the medical device company were to:…
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The word “harmonised standard” means a “European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation”, as per Regulation EU 1025/201. The prefix “EN” such as EN ISO 14971:2012 or EN ISO 13485:2016, are used to identify such standards. These harmonised standards are used to…
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In the medical device industry, standards play a vital role in product conformity while also helping Manufacturers synchronize with requirements of medical device regulatory bodies around the world. Product conformity to various national and international standards, as applicable, is important not only in the design and manufacture of medical devices but also to sell a…
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In January 2021, a new member, namely ISO 10993-23, of the ISO 10993 family was released. But what created the need for the introduction of this standard in the series of ISO 10993 standards? The purpose was to facilitate a comprehensive examination of a medical device’s irritation capacity. Since the standard’s release, there has been…
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The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals. The question which most of us have is: “What is new in the 2021 amendment of ISO 13485 standard?” Do not worry! We have the answers for that! This article focuses on the…
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Change – the necessity of time Changes in today’s world are inevitable, and this is all to keep abreast with the fast technological advancements and to keep the customers happy and content. But when you are in the medical device industry, something you cannot be naive about is that every change comes with a price. …
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A CE Marking is a much sought-after symbol, as it allows companies to gain access to the large European market. CE Marking indicates the conformity of products to the applicable regulatory requirements, and the performance and safety standards. It signifies that the product is suited for its intended use and won’t put people or property…
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Why RTA? The FDA conducts an acceptance review of a 510(k) submission (Traditional 510(k), Abbreviated 510(k), or Special 510(k)) against acceptance criteria to identify if the submission is complete or not. This acceptance review is known as the RTA review and it aids the reviewer in identifying the location of the document corresponding to each…
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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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