Quality Systems

We managed the quality assurance processes for a medical product sold world-wide

The FDA and International Medical Device Regulatory Agencies all require medical device manufacturers to implement and maintain quality systems describing their business operations related device design, manufacturing, sales and other related areas. Their intent is to ensure that medical device quality remains high, and that device safety and effectiveness meets regulatory objectives. This means a company must be able to prove to the regulatory bodies that its devices and internal business practices are of high quality, that problems and potential problems are being reviewed and addressed appropriately, and that the company maintains sufficient and appropriate personnel and resources to meet stated policies and objectives.

Acceptable proof of this includes documentation of business procedures (that show knowledge and compliance with the regulatory law), record keeping that demonstrates compliance with the procedures, and periodic audits by the regulatory agencies to verify procedures are acceptable, written, approved by management, and followed, and that records are sufficient, complete, and properly maintained. In short, review of the written procedures and records should demonstrate compliance with the regulatory law, and regular audits verify the paperwork accurately reflects business operations. STI has years of experience with FDA and international approvals, quality system regulation, and external audits, and can help you navigate these regulatory processes, so please contact us today!