Medical Electrical Device Registration
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01
Course description
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.
02
Course objective
Prepare participants to manage ANVISA regulatory processes for medical electrical equipment, integrating compulsory INMETRO certification, IEC 60601 series testing and the technical dossier.
03
Course programme
- 01
Definition of medical electrical equipment and risk classification
- 02
Compulsory INMETRO certification (Ordinance 384 and related provisions)
- 03
The IEC 60601-1 family and collateral/particular standards
- 04
Test report and certificate of conformity
- 05
Technical dossier and specific requirements for medical electrical equipment
- 06
ANVISA applications and INMETRO interfaces
- 07
Maintenance and post-registration changes
04
Who can attend?
- Regulatory Affairs professionals, electronic and biomedical engineers, Technical Managers, Quality professionals and medical electrical equipment manufacturers/importers.
Instructor
Laura de Pauli
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.