Glossary Term
Data Integrity
Definition
Data Integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. In the MedTech industry, it ensures that data generated, processed, and stored by medical devices and systems is complete, accurate, and protected from unauthorized modifications, supporting regulatory compliance and patient safety.
Relevance to the MedTech Industry
Data Integrity is vital for ensuring the credibility of clinical results, the reliability of medical devices, and the security of sensitive information. It underpins trust in MedTech products and compliance with global regulations such as FDA 21 CFR Part 11, EU MDR, and ISO 13485.
Additional Information & Related Terms
Cybersecurity for Medical Devices Protects data from unauthorized access or modification.
21 CFR Part 11 U.S. regulation governing electronic records and signatures to ensure data integrity.
ISO 13485 Quality management standard that incorporates data integrity as part of device lifecycle management.
Post-Market Surveillance Relies on accurate and consistent data for effective device monitoring.