MEDICAL DEVICE REPORTS (MDR) PROCEDURE (SOP 8-006)
The Medical Device Reports (MDR) procedure defines the decision process, including the use of internal decision trees, used to make Medical Device Reports (MDRs) to the FDA and provide instruction on how to file MDR’s. This procedure applies to all devices marketed in the United States unless excluded by FDA regulations.
FORM 0021 MDR Decision Tree
QMSM Quality Management System Manual
FDA Form 3417A FDA Baseline Report Form
FDA Form 3500A FDA Medwatch Form
21 CFR Part 803
FDA 510k medical device submissions, medical device process validation, medical device sterile packaging validations, medical device ISO 13485 quality system, medical device FDA QSR compliant quality systems, FDA QSIT audit preparation, FDA consulting, accelerated aging protocols, FDA QSR audits, ISO 13485 quality system certification support, modular iso 13485 quality system product, ISO 13485 quality system procedures