Those implementing and those auditing rarely speak in the same room. Over these two days, they will. On one side, HSC Global implements the programme and manages market entry, from software and UDI to clinical evaluation. On the other, UL Solutions and DNV, the auditing bodies, and a consultancy working within Canada.
Who is at the table?
Direct from CanadaLocal Health Canada consultancy, Day 1
The structure is repeated on both days: implementers on one side, auditors on the other. The roundtable brings the two perspectives into discussion.
Thursday, 1 October
13:00 to 16:30Brasília time
MDSAP strategy, market perspective, UDI, MDSAP, FDA, Health Canada and programme auditing. With Rosângela Laboni from UL Solutions, and Rucha Petel from Canada.
Access Day 1 on Teams
Tuesday, 6 October
13:00 to 16:30Brasília time
MDSAP strategy, software, usability and risk management, ANVISA medical device and in vitro diagnostic registration, ISO 14155:2026 clinical evaluation, ISO 10993:2025 biological evaluation and MDSAP auditing. With Baltazar Silvan from DNV.
Nicolas Crispim, HSC Global Group. Is MDSAP truly strategic?
Priscila Marques, HSC Global.
Mariana Barreira, HSC Global.
Flávia Alencar, HSC Global.
Rucha Petel, guest speaker.
Rosângela Laboni, UL Solutions.
Day 1 closes with a speaker discussion moderated by Nicolas Crispim (HSC Global).
Nicolas Crispim, HSC Global Group. Is MDSAP truly strategic?
Laura de Pauli, HSC Global.
Lucília Fialho, HSC Global.
Dr Juliane Rossato, HSC Global.
Baltazar Silvan, DNV.
Day 2 closes with a speaker discussion moderated by Nicolas Crispim (HSC Global).
Baltazar SilvanMDSAP Auditor, DNV
Day 2, Tuesday
From application to certificate: the objectives of Stage 1 and Stage 2, deadlines for addressing nonconformities, recommendation and issue. And how the auditing body shares reports with the jurisdictions.
When the auditing body must report results to each jurisdiction's authority and the circumstances triggering an unannounced audit.
How an MDSAP audit is conducted in practice, from the first audited process to the last, and what auditors look for at each stage.
Founder of HSC Global. Opening presentation (25 min): MDSAP strategy, market perspective. Is MDSAP truly strategic?
UDI (Unique Device Identification) specialist and HSC Academy instructor in UDI implementation.
Exemplar Global certified MDSAP Lead Auditor, with more than 8 years of experience and work across the programme's 5 countries. Specialist in ISO 13485 QMS implementation, regulatory affairs, RDC 665, MDR, ISO 14971 and internal auditing.
Pharmacist, with a specialisation and master's degree in Regulatory Affairs from IPOG. Exemplar Global certified FDA Medical Device Registration specialist, experienced in LATAM registrations, MDSAP certification and ISO 13485. Works at HSC Global as a Regulatory Affairs Specialist in FDA submissions and training.
Canadian consultant specialising in Health Canada medical device regulatory requirements.
UL Solutions MDSAP Auditor, an auditing body recognised in the MDSAP programme.
Mechanical Engineer specialising in Regulatory Affairs, with 14 years in technical product evaluation. Experienced in device design under ISO 14971 (Risk Management), IEC 62366 (Usability), IEC 62304 (Software) and the IEC 60601 series. MDSAP Lead Auditor, working in INMETRO conformity assessment and ANVISA, ANATEL and Dimel processes.
More than 20 years of experience in medical devices, in vitro diagnostics and cosmetics. ISO 13485 Lead Auditor (BSI), working in MDSAP and MDR. ANVISA IVD registration specialist, with an established record of successful ANVISA CBPF audits and ISO 13485 and ISO 9001 QMS certifications.
Biomedical scientist, PhD in medical device clinical and regulatory evaluation, with more than 20 years of clinical and preclinical research experience. Specialist in ANVISA submissions and projects involving stents, TAVI and nanotechnology. Co-inventor of an international patent and FINEP/TECNOVA-RS project leader. HSC Global consultant and instructor in clinical (ISO 14155:2026) and biological (ISO 10993:2025) evaluation.
DNV MDSAP Auditor, an auditing body recognised in the MDSAP programme.
Domestic manufacturers with export ambitions, with or without ISO 13485 certification.
Those needing to understand MDSAP's impact on the supply chain and the manufacturer's contract.
Internal auditors, quality coordinators and sector consultants.
Live online on Microsoft Teams. The access link will be emailed after registration.
In Portuguese, with simultaneous interpretation into English on both days. The Canada session on Day 1 is presented in English with interpretation into Portuguese.
Yes. Both days include a roundtable and a dedicated session for audience questions submitted through Teams Q&A.
No. UL Solutions and DNV participate as accredited auditing bodies in a strictly educational role. There is no cross-selling or mutual referral of services.
Yes. Both days are recorded, and the recording and materials will be sent to registrants after the event.
Each day has its own topic and stands on its own. Together, they form the complete pathway: Day 1 covers strategy, UDI, MDSAP, FDA, Health Canada and auditing; Day 2 brings together strategy, software, usability and risk management, ANVISA registration, clinical and biological evaluation and auditing.
1 and 6 October, 13:00 to 16:30. Live online on Microsoft Teams, in Portuguese with simultaneous interpretation into English. The recording will be sent to registrants after the event.
Questions about the workshop? Speak to us.
(11) 2574-0785
