Introduction When it comes to placing medical devices on the market in the European Union, the Medical Devices Regulation has taken the role of the Medical Device Directive (93/42/EEC). All prior notices pointed to the 26th of May, 2024 as the last day of the MDR transition phase. However, recently there have been some updates. …
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While food manufacturers must add additives to food products as required, however, it is also important to know the regulations applicable to both the additives and ingredients. Did you know not all of these additives are regulated and not all of them are free from the regulations? Confused? Here’s a sneak peek.
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Most consumers are aware that any cosmetic product contains a wide range of ingredients. However, it is the responsibility of the manufacturer to ensure that: We help Manufacturers do this by performing a thorough review of their ingredients based on the purpose of the product (E.g., lotion, scrubs, etc). Let’s take a look at an…
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A Companion Diagnostic (CDx) Device is often an In-Vitro Diagnostic (IVD) device that specifies the conditions for use of another product, like a drug or a biologic. A companion diagnostic may ensure the safety and effectiveness of a product. A CDx falls under the subset of biomarker-oriented testing. The test aids healthcare professionals in deciding…
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A grant proposal is a set of documents that are submitted to a company with the specific goal of receiving grants for a project. The process of drafting an effective grant proposal starts with a concept. To convince others to support your project, it is crucial to clarify the ultimate goal and purpose of your…
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What are cosmetics? Cosmetics are substances that are applied to the human body (except pure soap) to enhance beauty, cleanse, make it more appealing, or transform its appearance. They have no physiological impact on the body. Legally, a cosmetic will also be considered a drug, if it intends to alter the physiological functions of the…
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What are Dietary Supplements: Dietary supplements are additions to the standard diet which are quite distinct from the ingredients found in conventional foods. The use of dietary supplements has witnessed an upsurge in mass consumption over the past several years, as many people have made staying healthy and active a priority. These supplements are not…
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A grant is often given to an organization by a foundation, company, or governmental entity and is defined as “a financial donation provided to support a person, organization, project, or program.”. Grant money should account for 10% – 20% of your overall organization budget, depending on the sort of organization and industry. Grant Writing Grant…
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The market for biologics is expanding, and it is foreseen that it will grow at a Compound Annual Growth Rate (CAGR) of 9.22% during the subsequent five years. The COVID-19 pandemic had a considerable effect on the market, and there was a massive demand for biologics, which significantly fueled the market expansion. Since the COVID…
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“True prevention is not waiting for bad things to happen, it’s preventing things from happening in the first place.” Diagnosis in today’s world is much more powerful than it was ever before, and the reason behind is the meaningful data that these advanced diagnostic tools are powered by. As we know, data collection and monitoring…
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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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