01
Pathway and classification
Intended purpose review, classification rationale support, conformity-assessment planning and applicable requirements mapping.
European Union market access
EU MDR 2017/745 documentation and readiness support.
Structured assistance to help manufacturers organize the evidence and quality documentation required for the applicable conformity assessment pathway.
Core work packages
02
Technical documentation
Annex II / Annex III structure, device description, design and manufacturing information, GSPR checklist, labeling and evidence references.
03
Clinical and risk documentation
Clinical evaluation support, risk management traceability, benefit-risk documentation, and coordination of relevant evidence.
04
QMS and conformity assessment readiness
Documentation gap reviews, audit preparation, response tracking and support for interactions with the appointed conformity assessment body.
05
Post-market lifecycle
PMS, PMCF where applicable, PSUR where required, vigilance-process documentation and change-impact reviews.