ISOFACADEMY catalogue

Medical device training catalogue

Every programme is delivered by a practitioner active in the sector: certified ISO 13485 auditor, MDR regulatory affairs expert, risk management consultant.

Open-enrolment · In-house · Virtual classroom

E-learning modules? See the dedicated page →

European medical device regulation

MDR 2017/745 · CE marking · Economic operator obligations · FDA

IA-REG-01 1 day (7h)

Regulation (EU) 2017/745 — Fundamentals and scope

Audience Any professional operating within the medical device ecosystem — regulatory affairs, quality assurance, R&D, purchasing, production, general management — with no prior regulatory prerequisites.

Medical device training catalogue

European medical device regulation

Regulation (EU) 2017/745 — Fundamentals and scope

MDR in practice — Mastering the manufacturer's obligations end to end

MDR Technical Documentation — Building and Maintaining a Compliant File

CE Marking under MDR — From the technical file to market placement

Regulatory responsibilities according to your role — Manufacturer, authorised representative, importer, distributor

Importers and distributors under MDR — Mastering your obligations and securing your operational compliance

Unique Device Identification (UDI) — Compliance and implementation

Post-market surveillance and materiovigilance — MDR obligations and internal organisation

Drug-device combination products — Mastering the requirements of MDR Article 117

Devices without an intended medical purpose — Annex XVI of the MDR: scope and compliance

FDA Regulation and Access to the US Market — Mastering the QMSR (21 CFR Part 820)

Change control — Mastering product changes in Europe and internationally

Communication and advertising of medical devices — Mastering the regulatory framework and securing your practices

ISO 13485 Quality Management System

ISO 13485:2016 — Discovery and fundamental requirements

Build and deploy your ISO 13485 QMS from A to Z

ISO 13485 — Maintaining and optimizing a QMS in operation

Non-conformities, deviations, CAPA — Mastering the complete cycle in the medical device industry

RCA Investigation in the Medical Device Industry — The right tools, at the right time, with the right evidence

Validation of manufacturing processes — Building a solid file under ISO 13485 and MDR 2017/745

Personnel qualification in the medical device industry — From ISO 13485 §6.2 requirements to HR and managerial practice

Product release in the MD industry — A regulatory act, not an administrative formality

MDSAP — Decoding the audit model and preparing your QMS to undergo a single international audit

Product hygiene and safety in medical-device production — The right behaviors that protect the patient

Computerized systems compliance — ISO 13485, EU GMP and lifecycle management

FMEA applied to quality risk control in medical devices — The quality AND regulatory tool that your QMS must be able to defend

Internal, supplier and MDR audit

Conducting the ISO 13485 internal audit — Method, practice and reporting

Medical device supplier audit — Assessing and qualifying your subcontractors under MDR

Auditing under the requirements of MDR 2017/745 — Mastering the regulatory specificities that change everything

Behavioral and relational dimensions of auditing

Prepare and pass an ISO 13485 or MDR certification audit

Risk management

Mastering risk management according to ISO 14971:2019 — Principles and application to medical devices

Process Risk Analysis — Mapping and Operational Control

Product and process FMEA in a medical device environment

Cybersecurity of connected medical devices — Regulatory and technical requirements

Design, Development and Technologies

Design and development process under ISO 13485 — Architecture and documentation control

Usability — Integrating ergonomics and usability engineering from the design stage (IEC 62366)

Medical Device Software — Mastering the Life Cycle and IEC 62304 Compliance

MD Software in Agile Methodology — Adapting IEC 62304 to Iterative Development Modes

Managing an innovative medical-device project — Project management in the MDR regulatory environment

Eco-design and environmental performance of medical devices — Meeting market expectations

Biocompatibility and biological evaluation of medical devices — Demonstration of conformity according to ISO 10993

Medical devices of animal origin — Mastering regulatory requirements and building a robust file

Electrical safety and electromagnetic compatibility — IEC 60601 in practice

AI in medical devices — European Regulation on Artificial Intelligence (AI Act) and medical devices

Clinical evaluation, PMS and Vigilance

Clinical evaluation of medical devices — Choosing the right route and structuring your evaluation plan

Clinical Evaluation Report — Writing and maintaining an MDR-compliant CER

Clinical investigation — Regulatory framework, study design and conduct according to ISO 14155:2020

PMCF and PMCF — Designing and managing post-market clinical follow-up

Post-Market Surveillance — Structuring your PMS system and managing field signals

Materiovigilance — Organisation, mandatory reporting and crisis management

Production and Sterility

Mastering sterilization processes — Principles, standards and validation

Microbiology applied to the production of medical devices — Understand, control, prevent

Controlled Environments — Working in Controlled-Atmosphere Areas

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