Specialised Regulatory Services

UDI

• UDI roadmap across FDA GUDID, EUDAMED, UK, Health Canada, SFDA and NMPA
• Issuing agency coordination: GS1, HIBCC and ICCBBA
• UDI logic for configurable devices, kits and software
• Dataset authoring, XML generation and database submissions
• Barcode integration, print verification and legacy data migration

EUDAMED registration

• Actor registration and Single Registration Number (SRN)
• Basic UDI-DI and UDI-DI device data preparation and submission
• Bulk XML or machine-to-machine upload planning for large portfolios
• Data checks against labels and technical documentation
• Readiness for further modules as they become mandatory

Labelling & artwork

• Global labelling strategy for MDR, IVDR, FDA and UKCA
• Label content development and change-control workflows
• Symbol justification per ISO 15223-1, ISO 7000 and IEC 60417
• Barcode inspection and label validation against DMR and technical file
• Environmental marks for RoHS, WEEE and REACH

IFU & eIFU

• IFU content compliant with MDR, 21 CFR 801, TGA and UKCA
• Readability and usability testing with target users in 40+ languages
• eIFU platform set-up with QR and NFC access
• Accessibility reviews to WCAG and Section 508

Biocompatibility

• Biocompatibility strategy and gap analysis
• Biological evaluation plans and reports (BEP, BER)
• Chemical characterisation strategy
• Toxicological risk assessment per ISO 10993-17
• Justifications that leverage existing data and literature
• Responses to regulator questions on biological safety

Sterilisation validation

• Validation strategy and gap analysis
• IQ, OQ and PQ protocol development
• Ethylene oxide validation and optimisation per ISO 11135
• Radiation dose substantiation per ISO 11137
• Contract steriliser audits and revalidation planning

Human factors & usability

• Use specification and task analysis per IEC 62366-1
• Use-error hazard identification linked to the ISO 14971 file
• Formative studies: simulated-use, bench and remote
• Summative validation per FDA, MDR Annex I and MHRA guidance
• HFE/UE reports and special-population studies

Software & SaMD qualification

• Qualification as medical device software per MDCG 2019-11
• Classification under MDR Rule 11 and IVDR rules, and FDA device software functions
• IEC 62304 and IEC 82304-1 lifecycle documentation
• Clinical evaluation designed for software: valid clinical association, technical and clinical performance

AI/ML regulatory consulting

• AI/ML regulatory readiness assessment
• Alignment with EU AI Act requirements for AI-enabled medical devices and IVDs
• Good Machine Learning Practice deployment
• Algorithm change management and PCCP dossiers
• Technical documentation for AI-enabled software
• Explainability, transparency and data governance packages
• AI/ML risk management integrated with cybersecurity

Cybersecurity

• Cybersecurity maturity and gap assessment
• Threat modelling and security risk management linked to ISO 14971
• SBOM preparation and vulnerability monitoring
• Secure development lifecycle expectations per IEC 81001-5-1
• Premarket cybersecurity documentation for FDA and Notified Body review
• Post-market vulnerability management and coordinated disclosure

Obligations versus guidance. Legal requirements come from FD&C Act §524B for cyber devices in the US and the MDR and IVDR Annex I software and IT security requirements in the EU. Standards and guidance such as IEC 81001-5-1, AAMI TIR57 and MDCG 2019-16 describe how to meet them.

Environmental compliance

• RoHS material compliance and technical file preparation
• REACH SVHC screening and Article 33 communication
• WEEE classification, producer registration and reporting
• EU SCIP database submissions
• Packaging recyclability and environmental label review

Advertising & promotional compliance

• Claims substantiation and fact-checking dossiers
• Medical accuracy review by specialty-matched clinicians
• Copy review workflows for FDA, MDR, MHRA, TGA and CDSCO
• Review of print, web, social, video, congress and sales materials
• Claims renewal tracking as regulations change