EU MDR · IVDR · MEDDEV 2.7/1 DACH Region Specialists

Specialized Clinical Data
Extraction & Regulatory
Intelligence.

Delivering audit-ready MEDDEV 2.7/1 and EU MDR/IVDR compliance matrices for DACH MedTech manufacturers.

Operating Standards ISO 13485 ◆ EU MDR 2017/745 ◆ IVDR 2017/746 ◆ MEDDEV 2.7/1 rev.4 ◆ PMCF / CER

Market Access Focus

DACH-region MedTech manufacturers navigating European regulatory complexity.

MDR

Regulatory Framework

Full alignment with EU MDR 2017/745, IVDR 2017/746, and MEDDEV 2.7/1 rev.4 guidelines.

CER

Primary Deliverable

Audit-ready Clinical Evaluation Reports, extraction matrices, and gap analyses.

Core Competencies

Three disciplines.
One singular mandate.

Systematic literature review, critical appraisal, and structured extraction matrices built strictly for EU regulatory submissions.

MEDDEV 2.7/1 · PubMed · Embase

Alignment of clinical evidence with EU MDR/IVDR requirements. Identifying clinical deficiencies before Notified Body review.

MDR 2017/745 · IVDR 2017/746

Embedding clinical evaluation workflows directly into ISO 13485 quality management systems.

ISO 13485 · PMCF · SOPs