CRO & IVDR · IVDR Consulting
IVDR Strategy & Gap Analysis
Understand what your device needs for EU conformity assessment. We review the intended purpose, evidence and quality system, then define the work still required.
When this service helps
For a new EU submission, an IVDD-to-IVDR transition, or a change to intended purpose. Start with the existing file; the review does not assume that every study must be repeated.
Scope of work
Intended purpose and classification
Review device claims, users, specimens and applicable Annex VIII rules together.
Evidence and technical file
Map available results to safety, performance and documentation requirements; identify unresolved questions.
Quality system and submission
Review QMS readiness, conformity assessment options and notified-body scope where required.
What you receive
- Gap review
- Findings linked to the relevant requirement and available evidence.
- Action plan
- Prioritised tasks, dependencies, owners and information needed before submission.
What to prepare
Device description and IFU; intended markets; existing certificates; technical-file index; available performance results and QMS status.