Services

At MDR Consultants, we understand the importance of ensuring the safety of your medical devices and complying with regulatory and statutory requirements. That’s why we offer medical device consulting services and training courses to help you achieve your business goals and establish trust with customers.

With expertise in the medical device quality management system (QMS) and a deep understanding of the latest standards and regulations, including ISO 9001, ISO 13485, ISO 14971, UKMDR, MDSAP (Therapeutic Goods Administration (TGA) of Australia, Health Canada, Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil, Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, United States Food and Drug Administration (US FDA), European Medicines Agency (EMA) and the participating National Competent Authorities (NCAs) of European Union (EU) member states), EU MDD, and EU MDR, our team of experts has real-world experience in the industry.

Let us help you navigate the complex landscape of medical device regulations with our comprehensive consultation. We will work with you to understand your needs and provide a customized strategy for success, from internal audits to training and special projects to QMS.

Book your FREE consultation today and start achieving your business goals.