21CFR800-1299

Regulatory compliance: FDA

Your medical device company, as with all other medical device companies in the United States, must comply with countless regulations. This regulatory oversight keeps many potentially unsafe devices off the market, but it also requires all manufacturers to follow strict rules and guidelines. These rules have been tightened with the acceptance, in 1997, of the Quality System Regulation (QSR). The QSR includes the previously used Current Good Manufacturing Practice (cGMP) regulations. The full text of the Regulations can be found in the Federal Register 21 CFR Parts 808, 812, and 820. The QSR requirements focus on responsible and complete documentation, validation and verification of your design, production, and distribution processes.

In addition to these requirements, as a medical device manufacturer, you must prove that your device is safe and effective. Safety and effectiveness must often be proven through a "510(k) clearance" process, or a "PMA" (Pre-Market Approval) process. These processes require safety testing and occasionally, clinical trials of your device.

CE-Marking

For export to the European Union, your company needs to comply with the requirements of ISO 13485; these requirements are similar to but not the same as the QSR. In addition to this Quality Management System, the individual products must be issued a CE-Mark for EU distribution. BesTech will help you prepare the CE dossier, which is similar but not the same as the 510(k) submission document.

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