Delivering audit-ready MEDDEV 2.7/1 and EU MDR/IVDR compliance matrices for DACH MedTech manufacturers.
Market Access Focus
DACH-region MedTech manufacturers navigating European regulatory complexity.
Regulatory Frameworks
Full alignment with EU MDR 2017/745 and IVDR 2017/746 — medical devices and in vitro diagnostics.
Primary Deliverables
Audit-ready Clinical Evaluation Reports and Performance Evaluation Reports, extraction matrices, and gap analyses.
Manual literature screening remains a bottleneck in high-volume CER and IVDR workflows. We architect the extraction layer so your internal regulatory teams can focus on clinical strategy and Notified Body alignment.
Systematic literature review, critical appraisal, and structured extraction matrices built strictly for EU MDR and IVDR regulatory submissions — covering both clinical evaluations for medical devices and performance evaluations for in vitro diagnostics.
Alignment of clinical and performance evidence with EU MDR 2017/745 and IVDR 2017/746 requirements. Identifying deficiencies across both device and diagnostic submissions before Notified Body review.
Embedding clinical and performance evaluation workflows directly into ISO 13485 quality management systems — for both MDR device manufacturers and IVDR diagnostic producers.