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Relationship Between 21 CFR 820 and ISO 13485

1. Scope:

21 CFR 820: This regulation, also known as the Quality System Regulation (QSR), is specific to the United States and is enforced by the Food and Drug Administration (FDA). It applies to medical device manufacturers who intend to market their products in the US.

ISO 13485: This international standard is applicable globally and is widely recognized as a benchmark for medical device QMS. It is not specific to any country or regulatory body.

2. Regulatory Requirements:

21 CFR 820: The QSR outlines specific requirements that manufacturers must comply with to ensure the safety and effectiveness of their medical devices. It covers areas such as design controls, document controls, production controls, corrective and preventive actions, and more.

ISO 13485: This standard provides a framework for establishing a QMS that meets regulatory requirements in various jurisdictions. It focuses on risk management, customer satisfaction, process control, traceability, and continual improvement.

3. Documentation:

21 CFR 820: The QSR places emphasis on detailed documentation requirements. Manufacturers must maintain records of various activities such as design history files, device master records, complaint files, production records, etc.

ISO 13485: While documentation is important in ISO 13485 as well, it allows for more flexibility compared to the QSR. The standard requires documented procedures but does not specify detailed recordkeeping requirements like those found in 21 CFR 820.

4. Audits and Inspections:

21 CFR 820: Compliance with the QSR is subject to FDA inspections. Manufacturers may be audited by FDA investigators who assess their adherence to regulatory requirements.

ISO 13485: Compliance with this standard may be assessed through internal audits or third-party certification audits conducted by accredited certification bodies.

5. Post-Market Surveillance:

Both standards emphasize post-market surveillance activities such as complaint handling, adverse event reporting, product recalls, etc., but they may have different reporting requirements based on regional regulations.

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