IEC 62366-1 | Medical Device Usability
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Course description
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.
02
Course objective
Equip participants to conduct the medical device usability engineering process under IEC 62366-1:2015, producing the Usability Engineering File required by ANVISA, FDA (through HFE guidance) and the MDR.
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Course programme
- 01
Usability engineering fundamentals
- 02
Intended use, user profiles and use environments
- 03
Task analysis and identification of use-related risks
- 04
Formative and summative evaluation
- 05
Integration with ISO 14971 (risk)
- 06
Usability Engineering File
- 07
FDA (HFE/UE guidance) and MDR expectations
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Who can attend?
- R&D, Human Factors, Quality and Regulatory Affairs professionals, product designers and engineers involved in medical device development.
Certification
HSC Global Certificate Recognised by Exemplar Global RTP
Internationally recognised in more than 30 countries by Exemplar Global, with independent validation of the professional's technical competence.
Instructor
Laura de Pauli
Mechanical Engineer specialising in Regulatory Affairs, with 14 years' experience in technical product evaluation, IEC standards and ANVISA regulatory processes.
Mechanical Engineer specialising in Regulatory Affairs, with 14 years' experience in technical product evaluation and regulatory affairs. Extensive experience in product conception and design complying with ISO 14971 Risk Management, IEC 62366 Usability Engineering, IEC 62304 Software Life Cycle, and the IEC 60601 series on Basic Safety and Essential Performance of Medical Electrical Equipment.
Works in conformity assessment under the Inmetro process, covering a wide range of products such as medical electrical equipment, needles, syringes and infusion sets, with established experience in Anvisa, Anatel and Dimel regulatory processes.
Experienced in quality management systems complying with standards such as ISO/IEC 17025 and ISO 13485, and an MDSAP (Medical Device Single Audit Program) Lead Auditor.