Regulatory Requirements

The European Union Medical Device Regulation (EU MDR) ensures required standards of quality and safety, for medical devices being produced in or supplied to the EU. MQMS enables the CE marking process, as per EU MDR, as required for any organization producing or supplying medical device & related products, to the EU.

Health Insurance Portability and Accountability Act (HIPAA) is a US federal law, to protect electronic patient health information (ePHI). MQMS enables organisations in implementing HIPAA's privacy rule, and administrative, physical & technical safeguards, as per the Security Rule.

GDPR is an acronym for General Data Protection Regulation. GDPR regulates the processing of personal data, relating to individuals in the EU, by an individual, a company or an organization. MQMS provides consulting support to ensure GDPR compliance and data protection by design & by default.

CE marking indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. MQMS provides services that enable a successful transition from MDD, new CE required as per EU MDR, and IVDR.

The FDA is responsible for protecting the public health. It regulates the human and veterinary drugs, biological products, cosmetics and medical devices. FDA also periodically issues guidance documents. MQMS provides advisory support in implementation of FDA rules and guidances.