21 CFR Part 820 vs ISO 13485
ISO
13485 and 21 CFR Part 820 are both quality management system standards that
are significant in the medical device industry. While they share similar
objectives in ensuring the quality and safety of medical devices, they have
some key differences and serve different regulatory purposes.
ISO 13485: ISO 13485 is an international standard for
quality management systems specifically designed for medical device
manufacturers and their suppliers. It outlines requirements for a quality
management system where an organization needs to demonstrate its ability to
provide medical devices and related services that consistently meet customer
and regulatory requirements. ISO 13485 focuses on the entire lifecycle of a
medical device, from design and development through production, installation,
servicing, and disposal.
Key features of ISO 13485 include:
- Emphasis on risk
management throughout the product lifecycle.
- Focus on regulatory
compliance and meeting customer requirements.
- Requirement for
documentation of processes, procedures, and responsibilities.
- Emphasis on continual
improvement and customer satisfaction.
21 CFR Part 820 (FDA Quality
System Regulation): 21 CFR Part
820, also known as the Quality System Regulation (QSR), is a regulation
enforced by the US Food and Drug Administration (FDA) for medical device
manufacturers who intend to market their products in the United States. It
outlines specific requirements for the design, manufacture, packaging, labelling,
storage, installation, and servicing of medical devices. Compliance with 21 CFR
Part 820 is a legal requirement for selling medical devices in the U.S. market.
Key features of 21 CFR 820 include:
- Requirement for
establishing and maintaining a quality management system.
- Emphasis on design
controls, including design verification and validation.
- Requirement for process
validation and control.
- Emphasis on
documentation and recordkeeping, including device history records.
- Requirement for
handling complaints and adverse events.
While ISO 13485 and 21 CFR Part 820 regulations
share many similarities, there are also differences, particularly in terms of
regulatory requirements and specific emphasis. However, many medical device
manufacturers seek compliance with both ISO 13485 and 21 CFR Part 820 to ensure
global market access and regulatory compliance. Compliance with ISO 13485 can
facilitate compliance with 21 CFR Part 820, but manufacturers must ensure they
meet the specific requirements of each standard.
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