Medical devices – Quality management systems – Requirements for regulatory purposes 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!…
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What are UV light-emitting products? UV light-emitting devices are devices that are manufactured, distributed, or used to control, destroy or deactivate viruses, bacteria, or other microorganisms, or to reduce their levels, by means of UV radiation except in swimming pools, spas, or sewage treatment plants. UV light-emitting products are usually marketed as chambers (small/large), wands, and lamps. The…
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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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For a manufacturer of medical devices placed in a Magnetic Resonance (MR) environment, it is important to show compliance with the applicable regulations and standards, and this is primarily because the MR environment properties show extensive variations in different MR systems. Recently, the FDA has come up with new guidance that defines additional requirements for…
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Medical devices – What information is to be supplied by the manufacturer? As we are very much aware that the ISO 20417:2021 standard is already in town, Elexes Team has detailed in this article the need for the new labeling standard, ISO 20417:2021, which entails the information to be supplied by the manufacturers for a medical device…
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Several medical devices undergo clinical trials on an ongoing basis. Typically, medical devices are categorized based on their invasiveness, intended purpose, risks, and classification. The categorization of the medical devices serves as a guideline for the regulatory route to be adopted for marketing authorization in the country of interest and for determining the nuances to…
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As we know a medical device is a device intended for medical purposes. Such devices have numerous applications in the life of humans as well as animals. Some of it is the diagnosis, treatment, mitigation, prevention, and monitoring of diseases. As medical device usage can directly impact the health and life of human beings, it…
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Medical Device Development Medical device development is a comprehensive series of well-coordinated activities and events from the moment of product concept and ideation, to risk assessment and feasibility analysis, to design development verification and validation, leading to activities for the pre-launch preparation, and ultimately the product launch, market commercialization, and post-market surveillance. Medical device development…
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Introduction to Quality Management System Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on the health of the patients, and thus various regulatory bodies across the world also mandate the implementation of the Quality Management System (QMS) for which the most widely…
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Ever since the boon of the healthcare industry as one of the largest industries in the world market, multiple medical device companies have been designing and developing devices that are enhancing human lives. However, considering that healthcare is one of the highly regulated industries, it doesn’t come as a surprise that medical device companies often…
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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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