TESTIMONIALS

Dr. Korman Laboratories’ collaboration with Domo Salute has started in 2022 and we’ve been extremely happy with our choice of Regulatory Affairs partner in Brazil. This partnership has been instrumental in ensuring our compliance with INMETRO and ANVISA regulations to enable market access for our implantable devices.

Domo Salute provides high level of expertise in Brazilian regulations; their proactive communication style kept us informed at every step and gave confidence that our submissions are properly managed throughout the entire registration process.

Based on our successful collaboration, we highly recommend Domo Salute for any company seeking a reliable, knowledgeable, and results-driven Regulatory Affairs partner in Brazil. Domo Salute dedication to excellence in providing regulatory service support and maintaining medical device compliance has been invaluable.

Throughout the process, the ASPIVIX Team was highly impressed by the communication quality and the timeline’s efficiency. DOMO’s team consistently met all deadlines, ensuring our project moved forward to a successful submission and approval without unnecessary delays. Their proactive communication made collaboration seamless, and we always felt informed about our registration status.

Additionally, the quick resolutions to our inquiries were invaluable. Whenever we encountered questions or concerns, DOMO’s team promptly addressed them, which significantly contributed to a smooth registration experience. This level of support was greatly appreciated.

Overall, we are very satisfied with the support provided by DOMO and look forward to continuing our partnership in the future. We highly recommend DOMO to any company seeking a reliable and effective Regulatory Affairs partner in Brazil.

Quiero expresar mi más sincero agradecimiento por el excelente trabajo realizado en la consultoría para el registro de nuestro dispositivo médico ante los órganos regulatorios. Desde el primer contacto, su equipo se mostró siempre muy solícito y profesional, brindándonos orientación clara y oportuna en cada etapa del proceso.

Su conocimiento profundo sobre la legislación vigente y la capacidad de resolver nuestras dudas con precisión nos brindó una gran tranquilidad. Gracias a su conducción experta, el proceso de registro fue mucho más fluido y eficiente de lo que esperábamos.

I want to express my sincerest gratitude for the excellent work done in the consultancy for the registration of our medical device with the regulatory agencies. From the first contact, your team was always very attentive and professional, providing clear and timely guidance at each stage of the process.

Your deep knowledge of the current legislation and your ability to address our questions with precision gave us great peace of mind. Thanks to your expert management, the registration process was much smoother and more efficient than we expected.

The DOMO Team has helped us to register our medical device products in Brazil quickly and smoothly. We really appreciate the team’s kind support and professional help.

DOMO Salute helped us navigate the challenges of getting an AI Software as a Medical Device Solution through the ANVISA regulatory process and accelerated our path to device clearance.

DOMO team is extremely professional, we had flawless regulatory approvals for our products. This happens when the team has in-depth knowledge and communication is crystal clear, and DOMO has it all. Thanks for your support throughout the process and still continuing it.

At Labmaster Ltd., we are very pleased with the services of DOMO Salute to obtain Anvisa registration approvals smoothly for our In Vitro Diagnostic devices. DOMO Salute showed commitment and provided focused service on our registration projects. Amanda Frasson was very effective in preparing three submissions in a very short timeframe – we highly recommend their services.

It was a great experience working with DOMO. Thatiana was the main contact person and working with her has made my first time submitting an application to ANVISA a smooth and fuss free process. Thatiana takes her job at full responsibility and she went above and beyond to make sure I had all the information required to complete the required documents. DOMO is very well experienced in Brazil regulatory work and able to get the product registered in ANVISA within 1-2 weeks. DOMO is highly recommended and will continue to take up their services.

After a long search for a solid, professional and trustee hosting company in Brazil, we decided to select DOMO Salute to help us incorporate our ANVISA registration. The process included to secure the registration process & INMETRO requirements based on the Brazilian law. We were very impressed with the “full range” expert guidance & the comprehensive in-house corporate specialists provided to us to navigate the incorporation of the procedure. Nowadays and after the 1st shipment was entered to Brazil with no delay nor any unexpected lack of documents ect, we are confident, honored & happy to say that we are all ready and focusing in growing our business in Brazil. It’s refreshing to collaborate with a team that is at the top of its game. The overall process was professional and we are confident to recommend DOMO Salute to any medical device company who is in search for an ANVISA hosting company and office support.

I have been collaborating with DOMO Salute for registering our AI software-based products as medical devices in ANVISA. It has been a great pleasure to work with this professional team that has provided the best advice to make the best decisions in order to receive ANVISA registration successfully and in a short time.

We have been using DOMO Salute to register our AI application in neurology for clinical use in Brazil. We are very pleased with all aspects of DOMO salute’s work. They provided clear instructions around what material was needed and communication with staff was very friendly and competent, with quick answers to our queries. We received ANVISA registration of our products in an amazingly short time and we look forward to continue working with DOMO Salute for future registrations.

Collaboration with DOMO Salute has been a very pleasant experience. The process was smooth, friendly, professional and incredibly swift. This was our first registration in Brazilian markets and I’m very excited to get to know the Brazilian medical device field. New market is not scary at all when you working with DOMO Salute professionals.

On behalf of Max Cirúrgica, I would like to thank you very much for all services provided by DOMO Salute and its respective employees in the hiring and preparation of INMETRO certification and ANVISA product registration project. We were extremely pleased with all the service, agility, expertise of the team and all attention we received throughout the product certification and registration process that we hire under your advice. Thank you very much again and by our side you can be very sure that we will always work with DOMO Salute and point out to other companies that need a consultancy from excellent professionals like you.

As an international network of companies and healthcare providers it is crucial to rely on professional and trustworthy partners. We are happy to have found this partner in DOMO salute with whom we have already registered various medical devices without any objections. We were also surprised about the short time for registering our products.

We have been using DOMO Salute since July 2018, and I have to say that is has transformed the way we do registrations in Brazil.

DOMO Salute provides Med X Change with critical insight of the Brazil regulatory landscape, allowing us to make fast and educated decisions when it comes to the classification and registration of our products on this attractive market of Brazil. Their expertise on their market has helped us to optimize our registration process on terms of time and cost.

A very friendly, competent, and stable staff helps me find answers to my questions and concerns in a timely manner, and provide me with appropriate references to define the most efficient and financially course of action. The stability of their staff bring continuity to the projects and help expedite registrations within projected time for completion.

All this adds up to a very competent and committed partner willing to provide Med X change with the best regulatory advice when it comes to registrations in a highly attractive Brazil market.

I’m very happy for the value DOMO Salute brings to Med X Change, and I feel comfortable recommending them to any organization seeking a Sponsor and/or partner for the purpose of registering medical devices in Brazil.

It has been a great pleasure for me to work with the DOMO Salute team. We have already developed several projects together, all with great success, leading to obtaining the product registration before the expected deadline. Quick answers, differentiated service, highly trained professionals! We will certainly continue working together!