healthguard

Tools

Token cost is the o200k count of the tools list JSON, including schemas, before any tool is called.

• mdr_compliance_check

  EU MDR 2017/745 compliance assessment for medical devices. Checks CE marking, Notified Body, Clinical Evaluation, PMS, UDI, QMS, EUDAMED. Returns compliance score.

• ivdr_check

  EU IVDR 2017/746 in-vitro diagnostic device compliance. Risk class A-D, Notified Body requirements, transition deadlines.

• device_classification

  MDR Annex VIII medical device risk classification. Determines Class I/IIa/IIb/III based on device characteristics.

• udi_validate

  Validate UDI (Unique Device Identification) format per MDR Art. 27. Identifies issuing agency (GS1/HIBCC/ICCBBA).

• drug_interaction

  Basic drug-drug interaction risk check. Educational tool — not a clinical decision system. Checks known high-risk combinations.

• icd10_lookup

  ICD-10 code lookup and search. Covers common codes and chapter overview. Uses ICD-10-GM (German Modification).

• adverse_event_report

  Generate pharmacovigilance adverse event report template (MedDRA). Includes EU/DE/US reporting obligations and deadlines.

• gdpr_health_check

  GDPR Art.9 health data processing compliance assessment. Returns required legal basis, DPIA requirements, retention periods.

• hipaa_vs_gdpr

  HIPAA vs GDPR comparison for healthcare organizations. Side-by-side analysis with dual-compliance tips.

• clinical_trial_phases

  Clinical trial phase requirements under EU CTR 536/2014. Phase I-IV details, CTIS requirements, German specifics.

• gmp_checklist

  Good Manufacturing Practice (GMP) audit checklist per EU EudraLex Vol.4. QMS, personnel, premises, documentation, production, QC.

• medical_calendar_eu

  EU healthcare regulatory deadlines. MDR/IVDR transitions, AI Act obligations, NIS2, PSUR deadlines.