Physician-led clinical evaluations per MDR and MEDDEV 2.7/1 rev. 4 — modular, compliant, from a single source.
Seven implementation modules
Our proprietary implementation modules cover all typical questions manufacturers face — from initial consulting through gap analysis, scientific advice, clinical evaluation incl. clinical trials, clinical support and clinical writing with compliant documentation, to personnel development and process and quality optimisation. We are happy to write your complete clinical evaluation report according to MDR.
All CER evaluation modules can form the basis of a clinical evaluation document per MEDDEV 2.7/1 rev. 4.
Learn more (German) →We write your complete clinical evaluation report according to MDR.
Learn more (German) →MDR Annex XIV, Part A, section 1 requires a Clinical Evaluation Plan — we prepare it for you.
Learn more (German) →The stand-alone CEP with clinical development plan per MDR.
Learn more (German) →Data analysis of preclinical investigations as a building block of your clinical evaluation.
Learn more (German) →Physician-led analysis and appraisal of your product’s clinical data.
Learn more (German) →Literature route for the clinical evaluation — systematic search and appraisal.
Learn more (German) →Demonstration of equivalence as a route of clinical evaluation.
Learn more (German) →Procedure-compliant clinical documentation for your conformity assessment.
Learn more (German) →Where does your clinical documentation stand? We identify the gaps to MDR.
Learn more (German) →Ethical assessment of your medical device’s benefit-risk profile.
Learn more (German) →Clinical post-market surveillance and PMCF according to EU MDR Annex XIV.
Learn more (German) →Talk to us about your clinical evaluation.