Module spotlight: Clinical Evaluation
Regulators want proof that the benefits of your device outweigh its risks. Clinical evaluation builds that evidence and keeps it linked to the design and risk records it rests on.
By MoniDoseQMS Team
Clinical evaluation is where a device proves its case. It gathers and weighs the clinical evidence that the benefits of your product outweigh its risks — through literature review, clinical investigations, and benefit-risk analysis — and keeps it connected to the design and risk files it depends on.
What you can do
- Build clinical evaluations supported by literature reviews
- Plan and document clinical investigations
- Record benefit-risk analysis
- Keep clinical evidence linked to design controls and the risk file
Why it matters
EU MDR (Article 61 and Annex XIV) makes clinical evaluation a continuous obligation, and it feeds directly into post-market clinical follow-up. Keeping it inside the QMS means the evidence stays current and connected, not frozen in a standalone report.