HSC Training

Design Projects for
Medical Devices

A 40-hour specialisation in two parts (Design Fundamentals, 16 hours, and Advanced Project Management, 24 hours), guiding professionals from project concept to multi-jurisdictional submission, with Design Controls, risk management, V&V and complete technical documentation (DHF, DMR, DHR) under ANVISA, FDA (QMSR), CE/MDR and MDSAP.

40 hours across 18 modules 2 parts + integrated project ANVISA, FDA, CE/MDR and MDSAP
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The project journey

From project concept to multi-jurisdictional submission

Seven stages structuring a medical device project from start to finish, each with real documentary deliverables.

    Course programme

    18 modules, 40 hours

    A two-part programme: the comparative regulatory foundations and advanced project management with an integrated project.

    1

    How to develop

    Design Plan, scope, WBS, schedule, gates and governance.

    2

    Inputs and outputs

    Design Input, User Needs, Design Output, DMR and traceability.

    3

    Documentation

    DHF, DMR, DHR, V&V, change management and audits.

    Part 1, Fundamentals

    Medical Device Design Fundamentals

    16 hours, 9 modules. Comparative design regulatory foundations across three major global jurisdictions (ANVISA, FDA QMSR and CE/MDR), integrating Design Controls, risk management, technical documentation and clinical evaluation.

    Part 2, Advanced Management

    Advanced Medical Device Project Management

    24 hours, 9 modules and an integrated project. A step-by-step approach to developing, structuring and documenting a project from start to finish: from the Design Plan to a complete documentation dossier (DHF, DMR, DHR) ready for international audits.

    Skills developed

    What you will master

    Thirteen skills you can apply the next day, across both parts of the programme.

    Part 1, Fundamentals

    Regulatory foundations of design

    • Interpret and apply Design Controls under FDA 21 CFR 820 (QMSR) and ISO 13485:2016
    • Structure technical documentation under MDR 2017/745 Annexes II and III and the GSPR
    • Prepare an ANVISA registration technical dossier under RDC 751/2022 and RDC 665/2022
    • Conduct risk assessment integrated into design under ISO 14971:2019
    • Plan usability (IEC 62366-1) and biocompatibility (ISO 10993) requirements
    • Define multi-jurisdictional clinical evaluation and clinical evidence strategies

    Part 2, Advanced Management

    Complete project management

    • Develop a complete medical device project: from the Design Plan to multi-jurisdictional submission
    • Capture and document Design Inputs with bidirectional traceability (User Needs, Requirements, V&V)
    • Define measurable, traceable Design Outputs ready for Design Transfer
    • Create and execute V&V protocols under FDA (QMSR) and ISO 13485
    • Build DHF, DMR and DHR documentation prepared for international audits
    • Manage changes with regulatory impact assessment across ANVISA, FDA and CE
    • Apply agile methods adapted to regulated environments

    Methodology

    Classes with diagrams and comparative workflows

    Real industry case studies

    Workshops with documentary deliverables

    Exclusive HSC Academy learning materials

    Templates included

    Leave with documents ready to use

    Nine editable templates structuring your medical device project and technical dossier.

    Information

    Format and conditions

    Delivery format In person, Live Online or In-house
    Language Portuguese (references in English)
    Prerequisites Part 1: a degree in a related field. Part 2: completion of Part 1 or demonstrated equivalent knowledge.
    Assessment Part 1: practical exercises and a written assessment (70% pass mark). Part 2: workshops (30%), integrated project (50%) and participation (20%).
    In-house A customisable programme, with a tailored schedule and content.
    Who is this for?

    Professionals who design, register and document medical devices

    Five professional profiles that benefit directly from the programme.

    R&D and Design Engineers

    Professionals who need to understand regulatory requirements from the product concept stage.

    Regulatory Affairs

    Professionals involved in planning dossiers and multi-jurisdictional submissions.

    Quality and Compliance

    Those responsible for compliance with ISO 13485 and the project's Design Controls.

    Regulatory Consultants

    Professionals advising manufacturers on medical device development and registration.

    Professionals changing careers

    Those seeking to enter the medical device sector with a solid technical foundation.

    Certification

    Three certificates, one specialisation pathway

    Each part has its own certificate. Those completing both receive the full 40-hour Specialisation.

    1

    Part 1

    16 hours

    Medical Device Design Fundamentals. HSC Academy Certificate.

    2

    Part 2

    24 hours

    Advanced Medical Device Project Management. HSC Academy Certificate.

    3

    Complete

    40 hours

    HSC Academy Specialisation, Medical Device Design Projects (ANVISA, FDA and CE/MDR).

    All certificates include CPD Points and a statement of competencies aligned with RAPs and IRCA guidelines.

    Next step

    Master a medical device project from start to finish

    40 hours of multi-jurisdictional training, with an integrated project and ready-to-use templates. Speak to our team to reserve your place.

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