MDR/IVDR guidance, standards and notified-body expectations evolve continuously. Biolevate monitors versioned regulatory corpora and maps changes to technical documentation, GSPR, IFU, SSCP and quality evidence.
Faster MDR/IVDR impact review
Continuously compare MDR/IVDR guidance, standards and notified-body expectations against a versioned corpus and mapped technical documentation.
Versioned guidance change logs
Maintain monitored sources with refresh history and source-level deltas across guidance, standards, MDCG documents and notified-body feedback themes.
Faster technical documentation readiness
Turn detected changes into impact maps across GSPR, CER, PMS/PMCF, IFU, SSCP, risk files and QMS evidence.
How it works
1
Monitor MedTech sources — refresh MDR/IVDR guidance, standards, MDCG updates, templates and notified-body expectation signals.
2
Structure regulatory changes — capture source version, effective date, topic, applicability and changed requirement.
3
Map technical documentation impact — identify impacted GSPR, CER, PMS/PMCF, IFU, SSCP, risk and QMS sections.
4
Generate update actions — produce prioritized gaps, suggested updates and reviewer decision logs.
MDR/IVDR change monitoring: track deltas by source, device type, requirement topic, effective date and documentation area.
Technical-document impact mapping: link each change to affected sections, evidence needs, reviewer decisions and update actions.