Regulatory Compliance

Certificates of Compliance are regulatory documents to guarantee that a product is created exactly as illustrated and promoted. The FDA requires that these are kept on file for products relevant to its administration; while in the arena of medical products, ISO 9000 and ISO 13485 regulations must be documented. Every product that is built for a medical use has to have a device history record. We handle all aspects of documentation to meet current regulatory statutes and document corporate accountability.