Monique Greijmans

Your regulatory and quality partner, helps to speed up development & access to market and relieve your regulatory burden. Services: - Building a compliant regulatory strategy for product development and submission for market access. - Develop & establish a tailor-made QMS that fits your business objectives - Determining applicable regulatory obligations based on the product risk classification, - Coaching your staff to help improve their level of understanding on regulatory compliance Experienced in the application of: - regulations e.g., EU MDR 2017/745, EU IVDR 2017/746, EU AI Act, FDA 21 CFR 820, FDA 21 CFR part 11 - standards, e.g, ISO13485, ISO14971, ISO62304, ISO62366, ISO9001, ISO15189, ISO20387 - related guidelines EU and FDA. The expertise encompasses all aspects of complex product development in the regulated industry, from early research to market introduction till end of life. Managed a broad range of products in the pre- and post-market phase with the global market in mind, i.e., several types and combinations of software-only medical devices and AI applications, combined with imaging medical devices and/or IVD’s for healthcare solutions. Next to that, seasoned in process improvement, change management, team & people management, individual coaching & professional development, transformation of the organization, and Lean and Agile principles.