MEDICAL DEVICE REGULATORY TESTING AND CERTIFICATION

Comprehensive Regulatory Support for Medical Device Manufacturers

CertMed delivers end-to-end third-party regulatory services tailored to the needs of both active and inactive medical device manufacturers. Our comprehensive offering includes regulatory approvals, product testing and certification, auditing, cybersecurity and usability assessments, as well as training to support your compliance journey.

Whether you're preparing for market entry, maintaining certifications, or enhancing product safety and security, CertMed provides the expertise and insight needed to navigate complex regulatory landscapes with confidence.

Our Services

Validation/Verification Report

CertMed evaluates the accuracy of marketing claims related to product performance, functionality, and features—especially those not easily verifiable by end users. Our claim verification process is rigorous, repeatable, and independently conducted. Verified claims earn the right to display the CertMed Verified Mark, demonstrating that your product’s claims are supported by a trusted, science-based process.

Summative Usability Test Report

We plan, conduct, and document summative usability tests to validate that your market-ready product meets user requirements and ensures safe, effective use. These tests are designed to align with applicable regulatory requirements, including ONC safety-enhanced design guidelines, FDA submissions, and CE marking processes.

Human Factors Engineering Report

CertMed works closely with you to develop a clear vision of how intended users—such as healthcare professionals, administrative staff, or patients—interact with your product. We identify all user touchpoints to enhance the overall experience and ensure intuitive, safe, and effective design.

Cybersecurity Assessment Report

Our cybersecurity assessments identify critical assets, potential threats, and vulnerabilities. We evaluate both the impact and the likelihood of exploitation, helping to strengthen your product’s cybersecurity posture. CertMed’s analysis aligns with best practices and industry standards, including UL 2900, the NIST Cybersecurity Framework, and AAMI TIR57, ensuring your product meets the expectations of healthcare delivery organizations (HDOs) and regulators.

Informative Test Report

In many markets, an informative test report may be sufficient to demonstrate compliance or support product positioning. CertMed conducts evaluations according to EN standards or other applicable frameworks, issuing informative reports that reduce liability, support risk mitigation, and serve as credible market differentiators—even in cases where third-party testing is not mandatory.