FDA Quality System Regulation
Mar-Med Co. is an American company and is therefore registered with the FDA and regulated under the FDA's QSR system. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). These CGMP requirements for devices in part 820 (21 CFR part 820) were authorized by the Federal Food, Drug, and Cosmetic Act (the act). Mar-Med Co. dilligently maintains compliance with these regulations in order to ensure the high quality of our products.
ISO 13485 is the international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. Mar-Med is ISO 13485 certified, ensuring the quality of our products.
Notified Body - NSAI
The National Standards Authority of Ireland (NSAI) serves as our notified body. In that role, they serve as that guarantour that we maintain a quality system in compliance with ISO 13485. Chris Morrell, Vice President of the NSAI notes that, “By having ISO 13485 certification, those who use the Tourni-Cot product can have peace of mind in the quality of Mar-Med Co’s manufacturing and continuous improvement processes. We at NSAI hope that this certification opens up new markets for their Tourni-Cot product.”
Mar-Med products carry a CE mark, which means that we are compliant with the EU's Medical Device Directives. Any medical device placed on the European market must meet 'harmonized standards' to have a presumption of conformity to the Directives. The core legal framework consists of three directives: