Those who implement MDSAP and those who audit the programme, face to face. 1 and 6 October, live online, with HSC Global, UL Solutions, DNV and consultancy direct from Canada.
We cover the three regulatory pillars of your business throughout Latin America: auditing, implementation and training. All delivered by an Exemplar Global RTP for MDSAP.
Internal and second-party auditing aligned with leading global and Latin American regulatory frameworks. We identify gaps before the external auditor does.
Complete QMS implementation and regulatory dossiers for medical devices in Latin America, the USA and Europe. From gap analysis to final registration.
Lead Auditor qualifications and advanced international registration courses, with Exemplar Global certification recognised in more than 30 countries.
International manufacturer? Alongside consultancy, we act as your importer and registration holder in Brazil.
HSC Global is certified by Exemplar Global, an internationally recognised body for the qualification of professionals and organisations in management systems. This certification reinforces our commitment to excellence, credibility and worldwide recognition in training teams for the medical device sector.
Verify certificationWe work with the product categories that demand the greatest depth of regulatory and engineering expertise, from in vitro diagnostics to implantable devices.
Laboratory tests and reagents with their own regulatory framework, from classification to the technical dossier.
Medical equipment with requirements for electrical safety, performance and risk management.
High-risk products requiring biocompatibility, clinical evidence and rigorous traceability.
Diagnostic imaging systems with specific technical and regulatory requirements in each market.
Each project is led by accredited consultants and trainers, with a name, track record and public accountability for every opinion. MDSAP lead auditors, FDA specialists and a PhD in clinical evaluation who stand behind what they deliver.
CEO & Founder
Leads operations and domestic and international market development. Holds a postgraduate qualification from UNINOVE and has 15+ years in technology applied to healthcare.
SQA Lead Auditor
20 years as an SQA Lead Auditor and International Regulatory Affairs Specialist. Holds a master’s degree in Health Surveillance from Fiocruz and Lean Six Sigma certification.
Regulatory Affairs Specialist
Pharmacist with an MBA in Regulatory Affairs and Exemplar Global certification in FDA medical device registration. Nearly a decade working with Class I to IV dossiers, medical device vigilance and ANVISA inspections, as well as market access in Latin America.
Clinical and Biological Evaluation Consultant and Trainer
Biomedical scientist with a PhD in regulatory clinical evaluation of medical devices. 15+ years in clinical research and ANVISA submissions, and co-inventor of an international patent.
Regulatory Engineer
Mechanical engineer with 14 years in technical assessment of medical products, IEC and ABNT NBR standards, and ANVISA regulatory processes.
ISO 13485 and MDSAP Lead Auditor
Exemplar Global-certified ISO 13485 QMS and MDSAP Lead Auditor. Works with ANVISA and LATAM technical dossiers, registration across all classes and sterilisation process validation.
Regulatory Affairs and Quality Consultant, IVD Specialist
Pharmacist with over 20 years in Quality Assurance and Regulatory Affairs for healthcare products and IVDs. Established track record in CBPF, CBPAD, ISO 13485 and ISO 9001 certification.
MDSAP Lead Auditor
8+ years as an Exemplar Global-certified MDSAP Lead Auditor. ISO 13485 QMS specialist working across the five countries in the MDSAP programme.
“The project with HSC Global was fantastic. The support was attentive and thorough. The personal and professional growth has been immeasurable. Thank you to the whole team!”
“HSC’s MDSAP Lead Auditor course is excellent. It was extremely important for me to gain a deeper understanding of the auditor’s perspective, with a very practical approach aligned with the realities of auditing. The course brings together professionals with extensive experience, which greatly enriches the discussions.”
“I took the MDSAP Lead Auditor course with HSC Global and the experience was excellent. The training was essential in keeping me up to date with the latest regulatory requirements and better preparing me for the challenges of the medical device market.”
“The MDSAP Lead Auditor course certainly exceeded my expectations. Mariana demonstrated in-depth knowledge, with a clear, accessible approach and real-life situations that made the content much easier to understand.”
“The MDSAP course with HSC Global was truly excellent, providing high-quality training. It contributed greatly to my knowledge. I strongly recommend it to anyone wishing to develop their expertise in this area.”
“It was an extremely rewarding experience to learn through the project developed by HSC Global and its team. I intend to take part whenever possible and recommend it to everyone involved in Regulatory Affairs.”
“The courses are excellent, offering a wealth of knowledge and opportunities for participants to share their experiences.”
“The value HSC Global brings to HSC Global Medical is clear. Its work is marked by an innovative, strategic approach, always aligned with the highest standards and the real needs of the market.”
“HSC’s MDSAP Lead Auditor training is excellent. The trainer demonstrated in-depth practical knowledge of the subject, and the classes were dynamic, with team interaction. The course materials were readily accessible.”
“HSC Global’s courses have greatly enriched my knowledge. The content is well taught, and experiences are shared throughout every module. A professional, committed and flexible team, and an excellent choice for anyone seeking professional development.”
“When I first came to HSC Global, I was impressed by its substantial and comprehensive portfolio. During the MDR 2017/745 Lead Auditor course, I experienced the excellence of the training first-hand. It addresses broad and complex content in a practical, objective and contextualised way, supported by real-life examples and cases. I recommend HSC Global to professionals seeking a solid, high-quality qualification!”
SQA Lead Auditor and International Regulatory Affairs Specialist with 20 years of experience. Holds a master’s degree in Health Surveillance and Lean Six Sigma certification.
International Regulatory Affairs Specialist and Quality Management System Auditor with 20 years of experience in MDSAP, GMP and ISO auditing. Extensive expertise in international certification and ANVISA inspections, with an established track record in implementing medical device vigilance and pharmacovigilance systems.
MDSAP Lead Auditor certified by HSC Global (Exemplar Global), ISO 13485 Lead Auditor (BSI-IRCA) and ISO 14001 Lead Auditor. Academic qualifications include a master’s degree in Health Surveillance from INCQS/Fiocruz (2016-2018), a specialisation in Legislation and Health Surveillance from UFRJ (2009-2010), a degree in Pharmacy from Universidade Gama Filho (2006-2008) and a degree in Biomedical Sciences from UNIRIO (2000-2005). She is also studying Law at Estácio de Sá.
Certified as a Lean Six Sigma Black Belt by UNICAMP, with experience in KFDA (Korea), Chinese, FDA (United States) and LATAM regulation, CE marking and MDR (Europe). Fluent in English with advanced Spanish, with a track record of implementing MDSAP in more than 12 projects and conducting 10 second-party MDSAP audits.
Pharmacist with an MBA in Regulatory Affairs and Exemplar Global certification in FDA medical device registration. Nearly a decade working with Class I to IV dossiers, medical device vigilance and ANVISA inspections, as well as market access in Latin America.
Flávia Alencar is a pharmacist trained at Universidade Santa Cecília, with an MBA and a specialisation in Regulatory Affairs from IPOG. She has worked in regulatory affairs and quality management in the healthcare sector for nearly a decade. Her experience covers the preparation and maintenance of domestic and international registration dossiers for Class I to IV medical devices, changes and post-registration activities, medical device vigilance, CBPF and ANVISA inspections.
In Latin America, she develops market access strategies and manages registration processes with regional health authorities, supporting manufacturers in entering and expanding across multiple countries. This work led her to represent HSC Global at Meditech 2026 in Bogotá.
Certified by Exemplar Global as an FDA Medical Device Registration Specialist, she manages submissions to the US agency and works on quality management system certification under ISO 13485 and the MDSAP programme. At HSC Global, she is responsible for FDA submissions and training and teaches the FDA Registration Specialist course. Fluent in English and Spanish.
Mechanical engineer specialising in Regulatory Affairs, with 14 years of experience in technical product assessment, IEC standards and ANVISA regulatory processes.
Mechanical engineer specialising in Regulatory Affairs, with 14 years of experience in technical product assessment and regulatory affairs. Extensive experience in product conception and design in compliance with ISO 14971 for risk management, IEC 62366 for usability engineering, IEC 62304 for the software life cycle and the IEC 60601 series for the safety and essential performance of medical electrical equipment.
Works on conformity assessment under the Inmetro process across a wide range of products, including medical electrical equipment, needles, syringes and infusion sets. Also has established experience in Anvisa, Anatel and Dimel regulatory processes.
Experienced in quality management systems complying with standards including ISO/IEC 17025 and ISO 13485, and an MDSAP (Medical Device Single Audit Program) Lead Auditor.
Exemplar Global-certified MDSAP Lead Auditor, with over eight years of experience in implementing ISO 13485 QMS and working across the five countries in the programme.
CEO & Founder, HSC Global Group
Holds a degree in Commercial Management from UNINOVE and postgraduate qualifications in People Management and Digital Marketing. Has over 15 years of experience in commercial management and team leadership, supporting business development and growth in technology applied to healthcare.
At the helm of HSC Global Group, a technology company specialising in regulatory consultancy and quality management for medical devices, he leads operations, commercial strategy and domestic and international market development, connecting manufacturers with regulatory requirements in Brazil and leading global markets.
Biomedical scientist with a PhD in clinical and regulatory evaluation of medical devices. Over 15 years in clinical research and ANVISA submissions. Co-inventor of an international patent.
Consultant specialising in Regulatory Affairs and Quality Management for medical devices. Exemplar Global-certified ISO 13485:2016 QMS and MDSAP Lead Auditor, working on registration with ANVISA and Latin American regulatory authorities.
Pharmacist with over 20 years of experience in Quality Assurance and Regulatory Affairs in the healthcare products and in vitro diagnostics (IVD) industry. At HSC Global, she establishes quality systems, manages product and equipment registration with ANVISA and prepares companies to obtain their first CBPF, coordinating multidisciplinary teams towards regulatory compliance.
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Exemplar Global-certified MDSAP Lead Auditor