The clinical evidence
your submission needs.

Your notified body will scrutinise the CER more closely than almost anything else in your technical file. A weak CER — thin literature, poorly argued equivalence, inadequate state-of-the-art — is the most common reason for a major non-conformity on first review.

We prepare clinical evaluation reports per MEDDEV 2.7/1 rev.4 and EU MDR Annex XIV: state of the art review, equivalence assessment with full technical, biological and clinical justification, clinical data appraisal, and conclusions on clinical safety and performance. We work with your clinical team or operate independently using published literature.

Market entry is not the end of the regulatory obligation — for EU MDR it's arguably where the burden increases. You need a PMS plan before approval, a functioning data collection process, and periodic reports on schedule.

We build PMS plans and reports per EU MDR Article 83–86, including Periodic Safety Update Reports (PSUR) for Class IIa and above. We set up the data collection framework, define trend analysis thresholds, and prepare the report for your technical documentation — so PMS is a real process, not a document that sits in a folder.

When something goes wrong in the field, regulatory timelines don't move for you. We support serious incident classification, investigation, and reporting to competent authorities under EU MDR and CDSCO requirements — with clear, technically grounded reports that answer the regulator's questions directly.

For devices where the existing clinical data does not fully address residual risks or outstanding clinical questions, Post-Market Clinical Follow-Up is required. We design PMCF studies per EU MDR Annex XIV Part B — objectives, methodology, endpoints, and PMCF evaluation report template — proportionate to the device's risk classification and the gaps in the clinical evidence.