The process of post-market risk management is fascinating! This is an activity that encompasses every color of the rainbow; it includes post-market surveillance (PMS), a scientific method of evaluating internal and external information, followed by a CAPA when appropriate, ongoing monitoring of safety and performance, evaluation and mitigation of new risk, thereby preventing adverse or serious adverse events or product failures, or even recalls. Most regulatory agencies throughout the world, including the FDA, European Union (EU), MHRA, Health Canada and TGA, have ensured PMS and Risk Management for medical devices on a regulatory basis. This presents challenges for MedTech companies, especially those with medical devices that fit the definition of a software as a medical device (SaMD) or AI-based medical device. Regulators now place a greater emphasis on risk-based approaches than in the past because it has a direct impact on the patients or health care professionals. Healthtech is advancing faster than anyone could have predicted, therefore it is a valid concern that we keep up with the pace while still producing medical devices that are effective and dependable. For SaMD, keeping a careful eye on risk sources is crucial to ensuring that the organization has a proper approach for implementing controls and mitigating them before things go wrong. Join us on April 5 from 11:00 to 12:00 EDT as we talk about ways to make Software as a Medical Device (SaMD) post market risk management less complicated and more systematic for your company.
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Medical Device Expert & Consultant
An expert in medical and IVD devices & life sciences, Mr. Sundeep Agarwal is a speaker, trainer and consultant in the field of quality assurance, regulatory affairs, QMS, GMP, software validation, artificial intelligence, combination devices, GCP, design and development, risk management and industrial manufacturing. He is a lead auditor for medical devices and has expertise in ISO 13485, EU MDR, IVDR, CE Certification, CER, PMS, USFDA, 510(K), ISO 14971, MDSAP.