All medical device manufacturers supplying medical devices to the U.S. are required to maintain a quality management system in compliance with the Code of Federal Regulations (CFR) Title 21, otherwise known as 21 CFR 820. The quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.
21 CFR 820 Requirements
Manufacturers of medical device supplying to the U.S. are subject to inspection of their quality management systems for compliance with the requirements of 21 CFR 820. As a rule, this takes four working days and encompasses management, development, corrective and preventive action, as well as production and process control.
Manufacturers have to be prepared for the handling of FDA inspections, to prevent issues during the four days audits.
How can we help?
Our team includes Professionals with documented experience and former officials of the Notified Body TÜV SÜD Product Service (TÜV PS) and GxP Quality System auditors help our clients maximize the value of their products by developing innovative and cost-effective solutions, tailored to meet the needs and objectives of each and every client.
GemarMed’s experts have more than 20 years of experience in establishing and maintaining quality systems according to applicable regulatory requirements.
GemarMed can help clients by preparing for, participating in and serving as management representative in external 21 CFR 820 audits performed by FDA or Accredited Persons (AP)