Will the announcement and delays globally impact QMS?
Every once in a while, we see a paradigm shift in the industry about the planning and application of Quality Management Systems (QMS). Due to the ongoing regulatory changes, the healthcare or Medtech industry is well aware and confused about the changing requirements and standards. Below are examples of changes that happened in the past year alone:
On February 23, 2022, the FDA posted a proposed rule to change the Quality System (QS) Regulation’s requirements for CGMP for medical devices to become more in alignment with ISO 13485:2016. In the recent EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) session in Brussels on December 9, 2022, the members of the EU Council voiced their support for the European Commission’s proposal to postpone the deadline for approval of medical devices under the MDR.
Manufacturers are expected to have a quality system in place and assessed by a Notified body. Manufacturers may have found it almost impossible to adapt to the changes during the pandemic, but this is no longer the case. Instead of slowing down, the industry should view the recent paradigm shifts as a chance to get ahead of competition. This is an opportunity where one can prepare its quality and regulatory strategy, planned and optimized the expected cost of a robust QMS and regulatory activities, remote audits, etc. In a joint survey by IAF, ILAC and ISO, 91.5% participants felt that a substantial increase in remote techniques will stimulate the use of new processes. Therefore, the need for a robust QMS remains unchanged despite the announcement or delays and at the same time it has become more relevant; hence in this webinar, we will discuss:
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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.