With decades of experience, our MDR Consultants have the knowledge and hands on experience necessary to help your organization implement, monitor, and maintain and effective and lean quality management system in compliance and conformance with medical device industry specific national and international applicable statutory and regulatory requirements. Our consultants have extensive experience in working with organizations of all types and sizes as well as working for leading notified bodies as qualified medical device auditors. Our Consultancy services cover the following medical device industry criteria: ISO 13485, ISO 14971, MDSAP (Australia TG (MD) R & TG Act, Brazil Federal Law and RDC ANVISA, Canada (MDR) SOR/98-282 Part 1, Japan MHLW MO169 & PMD Act, US FDA 21 CFRs), EU MDD and EU MDR.