Glossary Term
Conformance Testing
Definition
Conformance Testing is the process of verifying that a medical device, system, or component meets specified standards, regulatory requirements, or design specifications. It ensures that the device functions as intended, aligns with industry standards, and complies with applicable regulatory frameworks such as ISO, FDA, or EU MDR.
Relevance to the MedTech Industry
Conformance Testing ensures that medical devices meet safety, performance, and quality standards. It provides regulatory authorities, healthcare providers, and patients with confidence in the reliability and efficacy of medical technologies, supporting market access and compliance.
Additional Information & Related Terms
ISO 13485 Governs quality management systems and includes conformance testing requirements.
Verification and Validation (V&V) Processes closely related to conformance testing, ensuring design outputs meet specifications.
Compliance Testing A broader term encompassing conformance testing for regulatory adherence.
Risk Management File Includes data from conformance testing to address identified risks.