Training that builds regulatory readiness.
Specialist courses in MDSAP, FDA, ANVISA, ISO 13485, MDR and IVDR, led by instructors who audit and implement QMS and regulatory affairs processes for medical devices and medicines.
MDSAP Lead Auditor, Excellence & Strategic Leadership
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24hISO 13485:2016 + RDC ANVISA 665/2022 + ISO 19011:2026 Internal Auditor
A 24-hour programme across 6 modules, integrating ISO 13485:2016, ANVISA RDC 665/2022, ISO 19011:2026 (4th edition) and ISO 14971:2019/Amd 1:2020.
Date to be confirmed
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40hMDR 745/2017 Internal Auditor
Internal Auditor training in the European MDR 745/2017 Regulation, covering GSPR, technical documentation, clinical evaluation and PMCF.
Date to be confirmed
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Coming soonMDSAP Internal Auditor
Training for MDSAP internal audit teams. Contact the HSC team for duration, format and dates.
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40hISO 13485:2016 Lead Auditor - Quality Management Systems for Medical Devices
A 40-hour programme (5 days) for third-party Lead Auditors in medical devices, under ISO 13485:2016 and ISO 19011:2026, aligned with Exemplar Global, IRCA and RAPS.
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40hISO 14001:2026 Lead Auditor
Lead Auditor training in Environmental Management Systems under ISO 14001:2026 and ISO 19011 guidelines, focusing on legal compliance and ESG.
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40hISO 9001:2026 Lead Auditor
Lead Auditor training in QMS under ISO 9001:2026 and ISO 19011 guidelines, for first-, second- and third-party audits.
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42hMDSAP Lead Auditor, Excellence & Strategic Leadership
42-hour training updated for the 2026 MDSAP AU P0002.011, with Exemplar Global certification.
Planned cohorts: 09/11 and 17/11
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24hClinical Evaluation - ISO 14155:2026 (ANVISA, FDA and CE Mark)
Clinical evaluation of medical devices under ISO 14155:2026, with a Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER) and PMCF.
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16hPreclinical Design Evaluation
Preclinical evaluation of medical devices, with physical, chemical, mechanical and biological characterisation and a reasoned justification for testing.
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16hPost-Market Control and Medical Device Vigilance
Post-market surveillance and medical device vigilance (VIGIMED/NOTIVISA), with MDR PMS/PMCF and FDA MDR/MedWatch.
Self-paced online
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40hMedical Device Regulatory Expertise with Artificial Intelligence
From classification to registration and dossier auditing, using Artificial Intelligence as a regulatory copilot.
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16hBiological Evaluation Dossier - ISO 10993:2025 (ANVISA, FDA and CE Mark)
Structuring the Biological Evaluation Dossier under ISO 10993:2025, with BEP, BER and a risk-based approach for ANVISA, FDA and CE Mark.
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