ISO 13485
An international quality management system standard designed specifically for the medical device industry. It imposes stricter requirements than the general ISO 9001 standard in the areas of risk management, design control, and regulatory compliance, and has been incorporated into the FDA's QMSR regulatory framework.
Timeline (last 90 days)
ISO 13485 §7.5 requires organizations to manage changes to approved documents in a controlled manner, ensuring that changes are reviewed and approved before implementation.
All compliant eQMS solutions design version binding to be non-retrospective, and its regulatory roots lie in the requirements of ISO 13485 §7.5 and 21 CFR 820.40 for controlled documents and record integrity.
Compared to the general-purpose ISO 9001, ISO 13485 imposes stricter requirements in risk management, design control, and regulatory compliance.
Regulatory documentation in the biomedical engineering field typically must comply with standards such as FDA 21 CFR Part 820, ISO 13485, or EU MDR.
ISO 13485 is the medical device design control standard, and IEC 61508 is the functional safety standard.
All Facts (5)
ISO 13485 §7.5 requires organizations to manage changes to approved documents in a controlled manner, ensuring that changes are reviewed and approved before implementation.
50%UnverifiedAll compliant eQMS solutions design version binding to be non-retrospective, and its regulatory roots lie in the requirements of ISO 13485 §7.5 and 21 CFR 820.40 for controlled documents and record integrity.
50%UnverifiedCompared to the general-purpose ISO 9001, ISO 13485 imposes stricter requirements in risk management, design control, and regulatory compliance.
50%UnverifiedRegulatory documentation in the biomedical engineering field typically must comply with standards such as FDA 21 CFR Part 820, ISO 13485, or EU MDR.
50%UnverifiedISO 13485 is the medical device design control standard, and IEC 61508 is the functional safety standard.
50%