Course Catalogue

A 24-hour programme training Internal Auditors for medical device Quality Management Systems, integrating ISO 13485:2016, ANVISA RDC 665/2022 and the guidelines of the new ISO 19011:2026 (4th edition). The only Brazilian course bringing together the four core QMS standards in a single programme, including risk management under ISO 14971:2019/Amd 1:2020, and placing international requirements such as FDA QMSR, MDR/IVDR, Health Canada, TGA and PMDA in context. It also covers advanced topics such as Software as a Medical Device (SaMD) and Computerised System Validation (CSV).

Who can attend?

Quality Managers and Coordinators responsible for the QMS at medical device manufacturers, importers and distributors Practising or trainee Internal Auditors conducting first- and second-party QMS audits Quality and Regulatory Affairs Engineers involved in regulatory compliance, ANVISA registrations, CE marking and certification Management Representatives responsible for implementing and overseeing the QMS under ISO 13485 R&D, Production and Clinical Engineering professionals involved in medical device design, validation and control Consultants specialising in quality, regulatory affairs and medical devices Importers and Distributors marketing medical devices and healthcare products in Brazil Technical Managers (pharmacists, engineers and other professionals designated as the responsible technical professional before ANVISA)

42-hour training updated for the 2026 MDSAP AU P0002.011, with Exemplar Global certification. November cohorts, live online. Full-time over 5 days or evening sessions of 3 hours 30 minutes. Technical basis: MDSAP AU P0002.011, revision dated 03/08/2026, and current legislation in the five jurisdictions.

Who can attend?

Lead and internal auditors who conduct or wish to conduct MDSAP audits. Regulatory affairs and quality management system consultants. Quality managers and coordinators at manufacturers that export or intend to export. Professionals who will lead the certification audit within their own company.

A Lead Auditor training course in Quality Management Systems for medical devices, comprising 40 hours (5 days) and focusing on third-party (certification) audits. Structured around ISO 13485:2016, in accordance with ISO 19011:2026 (4th edition) and integrated with the international regulatory context (ANVISA RDC 665/2022, FDA 21 CFR 820/QMSR, MDR 2017/745, IVDR 2017/746 and MDSAP), including risk management under ISO 14971:2019. Aligned with the Exemplar Global, IRCA and RAPS schemes, it prepares participants to pursue international Lead Auditor certification. Delivered in person or synchronously online (live).

Who can attend?

Internal and external QMS auditors Regulatory Affairs (RA) professionals Quality Managers and Coordinators Medical device and IVD consultants Certification Body and Notified Body professionals Technical Managers before ANVISA, FDA and competent authorities Professionals seeking international Lead Auditor certification

Lead Auditor training in Quality Management Systems under ISO 9001:2026, based on ISO 19011 guidelines and the requirements of internationally recognised accreditation bodies, for first-, second- and third-party audits.

Who can attend?

Quality professionals from any sector, internal auditors, consultants and prospective auditors for ISO 9001 certification bodies.

Lead Auditor training in Environmental Management Systems under ISO 14001:2026, based on ISO 19011 guidelines, preparing participants for EMS audits in organisations seeking legal compliance, ESG and environmental licensing.

Who can attend?

Environmental, sustainability, ESG, Quality and HSE professionals, internal auditors and prospective auditors for ISO 14001 certification bodies.

An Internal Auditor training course focused on the European Medical Device Regulation (MDR 745/2017), integrating the requirements of Annex I (GSPR), Annexes II and III (technical documentation), Annex XIV (clinical evaluation and PMCF), and the role of European competent authorities and notified bodies.

Who can attend?

Internal auditors, Regulatory Affairs, Quality and Clinical Research professionals, and consultants involved in CE marking projects under MDR 745/2017.

The MDSAP Internal Auditor course covers ISO 13485:2016, the MDSAP Audit Approach and the changes in ISO 19011:2026. Contact the HSC team to confirm duration, format, dates and fees.

Who can attend?

Internal auditors, Quality and Regulatory Affairs professionals, Technical Managers and prospective auditors at companies operating or intending to operate within the MDSAP scope.

Course content coming soon. Contact the HSC team for information about cohorts and the programme.

Course content coming soon. Contact the HSC team for information about cohorts and the programme.

An advanced HSC Academy course comparing medical device regulations in five Latin American countries (Mexico, Argentina, Colombia, Peru and Chile), using Brazil (ANVISA, RDC 751/2022) as the benchmark. Across 7 modules, the course covers authorities and legal frameworks, comparative classification, registration holding and local representation, reliance pathways and the use of foreign evidence (ANVISA, MDSAP and FDA), and harmonisation through IMDRF (N9 and N47), MERCOSUR Technical Regulations and MDSAP. The course also covers the use of generative AI in Regulatory Affairs within the QMS (ISO 13485): governance, tool validation, traceability, hallucination control and human review. Every requirement presented includes the standard and article, and every AI output is audited against the standard. A continuous case study runs through all 7 modules: medical electrical equipment with embedded software, ANVISA Class III, with an MDSAP certificate and FDA approval. Format: live online, 10 sessions of 4 hours (40h).

Who can attend?

Regulatory Affairs and Quality professionals already working on ANVISA medical device regulatory compliance. Prerequisites: - Practical experience with notification and registration under RDC 751/2022. - Knowledge of Good Manufacturing Practice (RDC 665/2022), ISO 13485 and ISO 14971. - Technical reading skills in Spanish. - Access to a generative AI tool for practical exercises. The course does not review basic Brazilian regulations, which are used as the comparison reference throughout all modules.

A course equipping professionals and companies to meet ANVISA health requirements for obtaining and maintaining the Operating Authorisation (AFE) and state and municipal health licences. Covers the regulatory framework applicable to medical device manufacturers, importers, distributors and warehouse operators.

Who can attend?

Regulatory Affairs professionals, Technical Managers (RT), quality managers, entrepreneurs and consultants working on establishing, maintaining or bringing medical device companies into compliance.

A comprehensive course on the ANVISA medical device notification and registration process, based on RDC 751/2022 and related legislation, covering risk classification, regulatory categorisation, structuring the technical dossier and electronic applications.

Who can attend?

Regulatory Affairs professionals, Technical Managers, Quality managers, consultants, medical device manufacturers and importers.

A course specifically addressing ANVISA regulatory compliance for in vitro diagnostic (IVD) medical devices, covering risk classification, technical dossier structure, analytical and clinical performance requirements, and the specific aspects of IVD product applications.

Who can attend?

Regulatory Affairs professionals, Technical Managers, clinical scientists, Quality managers and companies manufacturing, importing or distributing IVD products.

A course dedicated to the specific regulatory and technical aspects of medical electrical equipment, focusing on ANVISA requirements (RDC 751/2022), compulsory INMETRO certification requirements and the application of IEC 60601 series standards.

Who can attend?

Regulatory Affairs professionals, electronic and biomedical engineers, Technical Managers, Quality professionals and medical electrical equipment manufacturers/importers.

A course covering all medical device post-market surveillance obligations in Brazil (VIGIMED/NOTIVISA, medical device vigilance RDC) and their European (MDR PMS/PMCF) and US (FDA MDR/MedWatch) counterparts, including CAPA, trend analysis and the Periodic Safety Update Report (PSUR).

Who can attend?

Medical Device Vigilance, Regulatory Affairs and Quality professionals, Technical Managers, CAPA analysts and medical device risk managers.

A comprehensive course on the FDA (CDRH) medical device regulatory system, including risk classification, 510(k), De Novo and PMA regulatory pathways, the Quality Management System Regulation (QMSR, formerly 21 CFR 820), establishment registration and listing.

Who can attend?

Regulatory Affairs, Quality and R&D professionals, consultants and manufacturers seeking to market medical devices in the United States.

A strategic course on global regulatory governance for medical devices, covering the role of international organisations (IMDRF, GHTF/SG3), regulatory convergence, regulatory reliance, reference agencies and the development of integrated strategies for access to multiple markets.

Who can attend?

Regulatory Affairs managers and directors, strategic leaders, senior consultants, international market access professionals and decision-makers at medical device companies.

A comprehensive course on the UDI (Unique Device Identification) system applied to medical devices, integrating ANVISA, FDA (GUDID), European MDR (EUDAMED) requirements and IMDRF recommendations, focusing on practical implementation, issuing entity selection and compliant labelling.

Who can attend?

Regulatory Affairs, Quality, Packaging/Labelling, Logistics and IT professionals, Technical Managers and consultants involved in UDI implementation across multiple jurisdictions.

A practical course combining expertise in Brazilian medical device regulation with the use of Artificial Intelligence (Google Gemini) as an everyday regulatory copilot. Across two modules, participants progress from risk classification and notification of Class I and II products to registration, labelling and document auditing for Class III and IV products, applying AI to classification screening, application drafting, label review and dossier consistency analysis, always with critical validation.

Who can attend?

Regulatory Affairs and Quality Assurance professionals, Technical Managers, consultants and medical device manufacturer and importer teams seeking to incorporate Artificial Intelligence into their regulatory workflow.

A specialist course in Computerised System Validation (CSV) applied to the life cycle of systems used in regulated environments, based on ANVISA Guide 33, GAMP 5 principles, 21 CFR Part 11 (FDA) and data integrity requirements applicable to medical device manufacturers.

Who can attend?

Regulated IT, Quality Assurance, Validation and Regulatory Affairs professionals, Auditors and Technical Managers working in medical device companies, laboratories and ANVISA-regulated industries.

A course on the practical application of ISO 13485:2016 and RDC 665/2022 requirements to planning, controlling and documenting medical device design and development, structuring the Design History File (DHF) as expected by national and international regulatory authorities.

Who can attend?

Product engineers, Research & Development (R&D), Quality and Regulatory Affairs professionals, Project Managers and teams involved in medical device development.

40-hour specialist training in two parts (Design Fundamentals, 16 hours, and Advanced Design Management, 24 hours), covering Design Controls, risk management, usability, biocompatibility, clinical evaluation, verification and validation (V&V), and complete technical documentation (DHF, DMR, DHR) under ANVISA, FDA (QMSR), CE/MDR and MDSAP. Includes an integrated project with multi-jurisdictional submission.

Who can attend?

R&D and Design engineers, Regulatory Affairs, Quality and Compliance professionals, regulatory consultants and professionals moving into the medical device sector.

A comprehensive course on applying ISO 14971:2019/AMD1:2020 and ISO/TR 24971:2020 to the medical device risk management process, integrating the product life cycle with the Quality Management System and meeting ANVISA, FDA and MDR 745/2017 requirements simultaneously.

Who can attend?

Product engineers, R&D, Quality and Regulatory Affairs professionals, risk managers and auditors working on medical device development and maintenance.

A course dedicated to the specific application of ISO 14971:2020 and ISO/TR 24971:2020 to in vitro diagnostic (IVD) medical devices, considering the technical and regulatory characteristics of this product category, including analytical and clinical performance and the risk of incorrect results.

Who can attend?

IVD R&D and Quality professionals, Regulatory Affairs professionals, clinical scientists, engineers and consultants working in in vitro diagnostics.

A course focused on the medical device software life cycle under IEC 62304, covering safety classes A, B and C, integration with ISO 14971 (risk), ISO 13485 (quality), and ANVISA, FDA (including pre-market guidance) and MDR 745/2017 expectations for SaMD and SiMD.

Who can attend?

Software engineers, system architects, Quality and Regulatory Affairs professionals, R&D managers and consultants working with SaMD, SiMD and software embedded in medical devices.

A practical course on applying IEC 62366-1:2015 to the medical device usability engineering process, integrating task analysis, formative and summative evaluation, intended use and user profiles, aligned with ISO 14971 and FDA HFE/UE requirements.

Who can attend?

R&D, Human Factors, Quality and Regulatory Affairs professionals, product designers and engineers involved in medical device development.

The foundation course in the Special Process Validation series, establishing the scientific and regulatory basis for validating sterilisation, cleanrooms and sterile packaging in medical device manufacturing. Covers the regulatory imperative of ISO 13485:2016 (Clause 7.5.6), validation life cycle methodology (IQ/OQ/PQ), the risk-based approach under ISO 14971:2019 and integration across FDA QMSR (21 CFR 820.75), EU MDR Annex I, MDSAP Chapter 5 and ANVISA RDC 751/2022.

Who can attend?

Quality, Validation, Production, Engineering and Regulatory Affairs managers and coordinators working in the manufacture of sterile medical devices or devices produced in controlled environments Professionals needing a sound foundation before specialising in sterilisation, cleanroom or sterile packaging validation Consultants and Technical Managers involved in special process validation and audit preparation

An integrated course on validating special processes in medical device manufacturing (sterilisation, controlled environments/cleanrooms and sterile barrier systems), connecting ISO 13485:2016 (Clause 7.5.6), FDA QMSR, MDR 745/2017 and RDC 751/2022 requirements in a single, consistent view of compliance.

Who can attend?

Quality, Validation, Production, Engineering and Regulatory Affairs managers and coordinators, and consultants working in the manufacture of sterile medical devices or devices produced in controlled environments.

A course in the Special Process Validation series dedicated to validating medical device sterilisation processes. Covers microbiology fundamentals (D-value, z-value, SAL 10⁻⁶), method selection and an in-depth examination of the three most widely used methods (ethylene oxide under ISO 11135, radiation under the ISO 11137 series, and moist heat/steam under ISO 17665), as well as emerging methods (VHP, NO₂, dry heat) and cross-cutting topics, with requirements aligned with ISO 13485, FDA QMSR, MDR and RDC 751/2022.

Who can attend?

Validation, Quality, Process Engineering, Production and Regulatory Affairs professionals, microbiologists and consultants working in medical device manufacturing and outsourced sterilisation.

A course in the Special Process Validation series on the design, qualification and validation of cleanrooms and sterile barrier environments in medical device manufacturing. Integrates the ISO 14644 series (classification, qualification and operation), EN 17141 (biocontamination control) and the principles of the revised EU GMP Annex 1, covering classification fundamentals, design and commissioning, IQ/OQ/PQ, environmental monitoring programmes and contamination control, aligned with ISO 13485 and RDC 751/2022.

Who can attend?

Facilities and HVAC engineers, Validation, Quality, Microbiology, Production and Regulatory Affairs professionals, and consultants working with controlled environments in medical device manufacturing.

A course in the Special Process Validation series dedicated to the complete development and validation life cycle of sterile barrier systems (SBS) for medical devices, based on ISO 11607-1 (requirements for materials and systems) and ISO 11607-2 (validation of forming, sealing and assembly processes). Covers system architecture and material qualification, seal design and process development, IQ/OQ/PQ, stability and shelf-life studies, simulated distribution (ASTM D4169) and packaging integrity, meeting ANVISA, FDA and European notified body expectations.

Who can attend?

Packaging engineers, Validation, Quality, R&D, Process Engineering and Regulatory Affairs professionals, and consultants working in sterile medical device development and manufacturing.

A course integrating the updated requirements of the ISO 10993:2025 series with ANVISA, FDA and CE Mark regulatory expectations for structuring the Biological Evaluation Dossier, including the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER), focusing on a risk-based approach and minimising unnecessary testing.

Who can attend?

R&D, Regulatory Affairs and Quality professionals, toxicologists, biomedical engineers and consultants involved in medical device biocompatibility evaluation.

A structured course on conducting Preclinical Evaluation of medical devices, integrating physical, chemical, mechanical and biological characterisation, risk analysis (ISO 14971) and a reasoned justification for testing, aligned with ANVISA, FDA and European notified body expectations.

Who can attend?

R&D, Engineering, Quality and Regulatory Affairs professionals, consultants and laboratories working on medical device development and characterisation.

A course focused on Clinical Evaluation of medical devices based on ISO 14155:2026, integrating ANVISA, FDA and MDR 745/2017 (Annex XIV) requirements, covering the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), systematic literature searching and PMCF.

Who can attend?

Regulatory Affairs, Clinical Research, Medical Writing and Quality professionals, and consultants involved in medical device clinical evaluation.

A course on conducting medical device clinical investigations under ISO 14155:2026, integrating the ethical and regulatory requirements of CEP/CONEP and ANVISA in Brazil, FDA IDE in the USA and MDR Annex XV in Europe, focusing on GCP and research participant protection.

Who can attend?

Clinical Research, Regulatory Affairs and Medical Affairs professionals, study monitors, CROs and ethics teams involved in medical device clinical investigations.

Ongoing support for companies making high-impact regulatory decisions: entering new markets, navigating an audit, responding to a crisis or preparing for an investment round. Mentoring does not replace the internal team. It gives the Quality and Regulatory Affairs manager a senior adviser to help decide what to prioritise, how to justify decisions to the board and what to do when circumstances change.

Who can attend?

Quality and Regulatory Affairs directors and managers Founders and C-suite executives at expanding medical device companies International manufacturers preparing to enter Brazil and Latin America Companies undergoing due diligence, mergers, acquisitions or fundraising

An in-company training programme developed exclusively for your organisation. Unlike catalogue courses, HSC Global does not offer off-the-shelf content as in-company training: each programme is built from the ground up based on a company assessment, the actual product portfolio, device risk classification, QMS maturity and the regulatory markets in which the organisation operates or intends to operate. The result is training fully aligned with the client's operational, technical and strategic circumstances.

Who can attend?

Medical device and IVD manufacturers, importers and distributors, healthtech start-ups, multinational subsidiaries, CROs, laboratories and organisations wishing to train entire teams (Quality, Regulatory Affairs, R&D, Production, Sales) in a single technical programme applied to their actual circumstances.