MedTech market entry requires mapping technical documentation, intended purpose, claims and evidence against MDR/IVDR and local expectations. Biolevate compares dossier content with applicable requirements to produce source-linked applicability maps and gap lists.
Faster MDR/IVDR gap mapping
Compare technical documentation, intended purpose, claims and evidence against MDR/IVDR and local market expectations faster.
Section-level gap lists
Identify missing or weak content across GSPR, CER, PMS/PMCF, IFU, SSCP, risk files and QMS evidence.
Traceable market adaptation rationale
Link each gap and recommended update to the applicable requirement, device context, source evidence and reviewer decision.
How it works
1
Define device and market scope — select device type, intended purpose, claims, markets and documentation set.
2
Structure applicable requirements — load MDR/IVDR, guidance, standards and local expectations relevant to the device.
3
Map documentation gaps — compare requirements with GSPR, CER, PMS/PMCF, IFU, SSCP, risk and QMS evidence.
4
Generate update actions — produce prioritized gaps, source-linked rationale and reviewer-ready recommendations.
MDR/IVDR applicability mapping: connect requirements to device type, intended purpose, claims, evidence and documentation sections.
Notified-body-ready gap trail: every gap, rationale and decision is logged for technical documentation review.