Glossary Term
Conformity Assessment
Definition
Conformance Assessment is the systematic evaluation of whether a medical device or process complies with specified standards, regulatory requirements, or technical specifications. It involves testing, inspection, and certification to ensure that the product meets safety, performance, and quality benchmarks.
Relevance to the MedTech Industry
Conformance Assessment provides assurance that medical devices are safe, effective, and compliant with regulatory and industry standards. It is a critical step for market entry, maintaining regulatory compliance, and gaining the trust of healthcare providers and patients.
Additional Information & Related Terms
ISO 13485 A standard for quality management systems in the medical device industry that is often central to conformance assessments.
Verification and Validation (V&V) Activities that feed into the conformance assessment process by ensuring design outputs meet specifications.
CE Marking Requires conformance assessment as part of the approval process in the European Union.
Notified Body Third-party organizations often involved in conformance assessments under EU MDR or IVDR.