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Manufacturers who want to sell their medical devices or IVDs in the United States must comply with 21 CFR Part 820 of US law. This section of the US Code of Federal Regulations specifies the quality system requirements for medical device and IVD manufacturers and is commonly referred to as the FDA GMP (Good Manufacturing Practice). FDA GMP for medical devices requires manufacturers to implement a quality system for the design, manufacturing, packaging, labeling and storage of the products.
Emergo Group is an experienced FDA GMP consulting firm that has implemented hundreds of GMP and ISO Quality Management Systems (QMS) for medical device and IVD manufacturers in North America, Europe and Asia. Our FDA GMP consultants have implemented quality management systems for companies with a diverse range of medical devices and manufacturing processes. Also, our consulting team is equally experienced with ISO 13485 and we typically implement it at the same time an FDA GMP system is being established. This allows companies to have a seamlessly integrated FDA compliant quality system that also meets international requirements for Europe, Canada, Japan, Australia and more. If you already have ISO 13485:2003 certification, we can assist you in integrating FDA Good Manufacturing Practice into your existing QMS.
Let our FDA GMP consulting team put you on the path to compliance and open the doors to new sales opportunities in the United States and worldwide.