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.
“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!”
Regulatory updates, case studies and practical guides written by those who audit and implement systems in the medical device and pharmaceutical sectors. See what is new.
