Background A manufacturer developing healthcare products planned to expand their existing team for designing, manufacturing, and marketing and sought to register their products in the markets worldwide. However, they were concerned about the description of job requirements, the candidate shortlisting process, the training process to be followed after the onboarding of employees, and maintaining respective…
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Background A medical device manufacturer (legal manufacturer) developing therapeutic lasers and based in the United States had their contract manufacturer based in India. The contract manufacturer was responsible for the development and production of therapeutic lasers as per the service agreement. The contract manufacturer was bound to undergo a supplier audit in line with the…
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Radiological computer-assisted triage and notification software is a form of image processing software. Based on computer-assisted image analysis done by the device, the device alerts a predefined list of doctors when time-sensitive radiological medical images are available for examination. Using the analysis of medical images obtained from radiological signal collection systems, radiological computer-assisted triage and…
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Background A medical device company was looking to understand the FDA classification and regulatory framework that is needed to be considered for an Automated Breast Ultrasound (ABUS). The company wanted to engage a qualified and skilled team to help them with various problems that they were facing in getting ABUS to the market, and hence…
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Background An in-vitro diagnostic (IVD) manufacturer was not familiar with the EU regulations and wanted to understand the general requirements that were needed to be fulfilled in order to market their products. The device utilized cardiac enzymes, also referred to as cardiac biomarkers, to identify and treat certain cardiovascular ailments. The quantification of these biomarkers…
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BackgroundAn In-Vitro Diagnostic (IVD) manufacturer intended to market their product in the US; the device used whole blood, blood plasma, or serum to detect HIV in the specimen. The IVD utilized an antigen/antibody (Ag-Ab) combination for detecting the presence of HIV antigens and antibodies in the specimen. The device aided in qualitatively detecting the presence…
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A medical device manufacturer approached Elexes with a High-Intensity Focused Ultrasound (HIFU) device intending to be placed in the US market. The device is capable of delivering HIFU energy that disrupts subcutaneous adipose tissue (SAT) and provides a non-invasive approach to achieve the desired aesthetic effect. The device aims at non-invasive waist circumference reduction. The…
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Overdosing on a few medicines can have disastrous repercussions on the human body. Many manufacturers are working to develop drug monitoring systems that can detect a patient’s drug levels in the bloodstream and further adjust treatment and dosages to avoid potentially disastrous outcomes. By definition, a drug monitoring device usually measures the number of specific…
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DHF New Product Introduction (NPI) Challenges Solutions & Results The solution to the Company’s challenges were offered by Elexes and comprised of 6 primary elements P3C3 The resulting DHF was in compliance with ISO 13485, ISO 14971, IEC 62304, IEC 60601, and other applicable product specific standards and was reviewed and accepted by the regulatory…
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A dilemma of many general wellness product companies Background A medical and wellness device manufacturer wanted to launch one of its devices, in the form of a wearable, that records, stores, analyses, and transfers single-channel electrocardiogram (ECG). The device utilized certain algorithms available through apps on Apple iOS and Google Android-based smartphones to analyze the…
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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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