The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices for which there are no legally marketed predicate devices. It is one of the least used pathways by medical device manufacturers when bringing a product to market because of the associated data requirements,…
Read article
While the preamendment devices can serve as excellent predicate devices, there are practical challenges associated while using such devices for approvals. One such example is that of a surgical mesh. The U.S. Food and Drug Administration (FDA) on April 16, 2019, ordered the manufacturers of surgical mesh, indicated for the transvaginal repair of pelvic organ…
Read article
Diagnosis plays a vital role in curing a disease. If the diagnosis itself is wrong, the disease cannot be treated. Osteosarcoma, a dangerous but common form of bone cancer which mostly affects the population of children and young adults (15 – 24), is often being misdiagnosed as growing pains or muscle strains, according to the…
Read article
While there existed many computerized and digital tomographs with specific applications (Trauma CT, Cardiac CT, CT used in Nuclear Medicine / PET), there has never been one with an application in the respiratory space. Electrical impedance tomography (EIT) is a noninvasive, non-radiologic imaging modality that is useful for the assessment of lung disorders during mechanical…
Read article
Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy? These aspects if compromised, can result in enormous adverse effects and are simply non-negotiable! Let’s take a look at how one can prove their devices to be safe and effective and ensure high quality throughout its life. ISO…
Read article
What is continuous improvement and how can we achieve it? An answer to this is a premeditated and well-implemented quality management system (QMS). A QMS, in simple words, is a system in which documents on various processes, relevant to the medical device or activities around it, are maintained. This does not mean that QMS is…
Read article
Standards are considered an integral part of product design & development. Standards are very important in medical device applications. Some of the most critical standards exist in the medical device industry for ensuring the electrical safety of devices. Millions of electronic devices that produce electricity or work on it, rely on IEC (International Electrotechnical Commission)…
Read article
Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices? We understand! read below to learn about some document control systems that can help make almost any business more efficient. Due to the very nature of…
Read article
The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics. The advisory committee protects and promotes public health while meeting the requirements established in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the…
Read article
Globalization and international trade has drastically changed the face of the world. In the last couple of years, communication and trade has bloomed between the developed and developing countries. The wave of globalization, in the healthcare domain, has resulted in a surge of import and export of medical devices to various parts of the world…
Read article
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.
Skills:
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.
Skills:
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.
Skills:
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.
Skills:
