21 CFR 820 (QSR)
Chapter 21 CFR820 also known as QSR (Quality System Regulation) outlines the good manufacturing practices that govern the methods used, the structures and controls necessary for the design, production, packaging, labeling, storage, installation and maintenance of all medical devices and IVDs intended for human use.
These requirements are designed to ensure that medical devices are safe and effective.
Manufacturers of medical devices wishing to sell in the USA are subject to FDA inspections to ensure compliance with FDA 21 CFR 820.
Maytal is able to support manufacturers of medical devices and IVD, who intend to export to USA:
These requirements are designed to ensure that medical devices are safe and effective.
Manufacturers of medical devices wishing to sell in the USA are subject to FDA inspections to ensure compliance with FDA 21 CFR 820.
Maytal is able to support manufacturers of medical devices and IVD, who intend to export to USA:
- to implement the Quality System in compliance with the requirements of 21 CFR820;
- perform internal audits and/or audits to outsourced suppliers in compliance with the requirements of 21 CFR820;
- carry out Mock Audit preparation for the FDA audit in order to assess whether the organization is "ready" for an FDA audit;
- assist the company with the FDA audit
