Regulatory Compliance,
Gap Analysis & Remediation

Overview

The Regulatory supervision in Medical Devices and diagnostics industries is expanding as the regional Health Authorities and global regulators work to improve patient safety by minimizing the risk of device-related injuries and adverse events. To ensure compliance with medical device GMP requirements beforehand, it is required that compliant quality systems be in place and that employees in all facilities and at all levels are fully aware of and adhere to these quality systems. 

GMP requirements for Medical Devices vary for different countries. Main regulations or guidelines related to quality management systems are ISO 13485:2016 and 21 CFR 820. Manufacturers aiming to market the devices in the EU region must comply with ISO 13485:2016 requirements and obtain certification from a Notified Body. This certificate is mandatory to obtain CE marking of devices. Manufacturers with an intention to enter the U.S. market shall comply with 21 CFR 820 regulations. There are common Medical Device Regulatory compliance and certification programs, such as, MDSAP which are accepted by multiple Regulatory bodies including, the US FDA, Health Canada, TGA, PMDA, ANVISA, etc. Such certifications prove promising for the Manufacturers targeting multiple countries. Other countries have their own medical device quality management system requirements. However, majority of other countries accept the certificates issued by the reference countries.

Establishing Medical Device QMS systems that are compliant with Regulatory requirements of multiple Health Agencies is a great challenge for device manufacturers. It is further complicated in cases where the Contract Manufacturing Sites are involved and medical device compliance requirements for each stake holder varies in each country. 

Freyr’s expert Medical Device RA professionals assist the organizations by providing medical device GMP compliance services through support in establishing compliant quality management system, carryout medical device gap analysis or medical device assessment as mock audits, internal audits, training the resources, conducting Medical Device gap analysis of established Quality systems for compliance with current Regulatory requirements and finally handling remediation, so as to obtain medical device GMP compliance successfully. The GMP compliance services include, end-to-end support for GMP compliance Audit ready QMS systems for the manufacturer.