Medical Device cGMP Services
For Medical Device Quality Systems Regulations, a mock-FDA, Quality Systems Inspections Technique (QSIT) inspection can be performed depending on your company’s need.
The various subsystems reviewed can encompass the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use.
In addition, an audit can be conducted to the criteria of ISO 13485:2016 Standard for preparing for this certification or for a gap assessment for non-conformance findings to this standard.
The compliance with cGMPs in to ISO 13485:2016 and 21 CFR part 820 are intended to ensure that finished devices will be safe and effective. Click this link for more information on part 820 regulations.
The QSIT guide is used by FDA Investigators when performing compliance inspections to evaluate a medical device manufacturer's compliance with the Quality System Regulation and related regulations. Click this link for how FDA inspects medical device facilities and valdation of medical device designs.
