FDA Warning Letters have doubled. The agency is strictly enforcing response timelines. New investigators are being added to the Office of Regulatory Affairs. International inspections are expected to double. Do you have an inspection procedure? Are your personnel trained in inspection processes?
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ISO 13485:2003 is still the standard for medical device quality systems, although it is being reviewed for update. The quality system is based on a process model. ISO 13485:2003 requires a Risk Management process and refers to ISO 14971. Additionally, products certified to IEC 60601-1 Third Edition will require the use of a ISO 14971 Risk Management process. Also, FDA requires compliance with Quality System Regulation 21 CFR 820, which is harmonized with ISO 13485:2003.