It is crucial to rely on professional and trustworthy partners. We are happy to have found this partner in DOMO Salute.

– Tobias Zobel, Director of the d.hip and Ambassador of the Medical Valley, EMN, Germany (Germany).

 

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

– Edwin Martinez, Director of QA/RA MedXChange (USA).

 

health regulatory consulting

Our team of regulatory affairs professionals has a wealth of regulatory experience that covers all the requirements related to medical device’s registration in Brazil. Together we know this industry inside out.

ABOUT US

We are a medical device regulatory consulting firm assisting foreign companies through the Brazilian regulatory system, enabling their access to our growing market.

 

We are proud of our experienced and adaptable team of consultants who have extensive experience in the fields of regulatory strategies, audits, applications and interaction with the Brazilian authorities, such as ANVISA, INMETRO and ANATEL.

 

We provide a client-driven, just-in-time consulting service, focused on delivering highly individualized regulatory solutions. DOMO Salute means House of Health and it reflects our desire to promote a positive atmosphere and build a trust-based partnership with all our clients.

 

Every project is treated uniquely. What this means is that you can expect a high quality, structured, professional approach to all phases of your project.

WHY DOMO?

EASILY ACESSIBLE

Our team of experts is friendly and easy to approach, you are free to ask any questions and DOMO will get back to you in a very short time.

CUSTOMIZED SOLUTIONS

One size does not fit all. DOMO takes time to understand your product and offers technical guidance that is built specifically for you.

NO SURPRISES

From the beginning you will know exactly the paths your medical device will take and the total cost of the project.

SAFETY

We handle your regulatory project very carefully.

TESTIMONIALS

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 [...]
– Marli Vieira – Regional Business Director Latin America, Gelita Medical GmbH (Germany)
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 [...]
– Edwin Martinez – Director of QA/RA, MedXChange (USA)
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 [...]
– Tobias Zobel – Director of the Digital Health Innovation Platform (d.hip) and ambassador of the Medical Valley EMN (Germany)
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, [...]
– Emerson Almeida – National Manager of Sales and Products, MaxCirúrgica (Brazil)
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 [...]
– Laura Mattinen – Etsimo Healthcare (Finland)
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 [...]
– Lennart Thurfjell – CEO, Combinostics (Finland)

OUR KEY EXPERTS

Our experts look forward to bringing unique capabilities and approaches to your company. Get to know the members of our team and find out what they bring to our company

Diego Louzada, Ing.

Business Development Manager

Diego Louzada, Ing.

Business Development Manager

16 years ago, he started working for an INMETRO/ANATEL/ANVISA accredited test laboratory. Since then, he has been developing a deep knowledge of the Brazilian regulatory system. Diego has worked for the past eight years assisting companies getting their INMETRO/ANATEL
certification. He has been working as a regulatory affairs consultant building strong relationships with regulatory agencies, accredited test laboratories and players from the Brazilian health market. Diego brings a fresh view to every project, has great communication skills and works opening new markets and building trust-based long lasting relationships.

Thatiana Terroso, Pharm, PhD.

Regulatory Manager.

Thatiana Terroso, Pharm, PhD.

Regulatory Manager.

Thatiana has a Pharmaceutical-Industrial degree, obtained her masters and PhD degree in Pharmaceutical Science, having focused her academics studies in Nanotechnology and she also completed a MBA on Innovation Management. Before joining DOMO, Thatiana worked as a consultant for technological innovation projects, nanotechnology cosmetics laboratories and industries. She applies her deep product development knowledge assisting companies register their devices in Brazil. Over the past years she has acquired a profound comprehension of ANVISA’s regulatory guidelines. Thatiana is always able to understand your devices’ unique needs and determine the best approach for your regulatory strategy.

Amanda Frasson, Pharm, PhD.

Regulatory Manager.

Amanda Frasson, Pharm, PhD.

Regulatory Manager.

Amanda obtained her PhD degree in Pharmaceutical Science from a Brazil-Canada cooperation. Having managed a variety of regulatory and quality assurance projects, Amanda has grown to become an expert able to support global companies. With her background she is able to assist clients with the Brazilian regulatory requirements, having completed many regulatory applications for GMP certification and product registration. Amanda is always focused on providing a high quality structured service to all clients.

Maike Reuwsaat, Pharm.

GMP Quality Management System Specialist.

Maike Reuwsaat, Pharm.

GMP Quality Management System Specialist.

Industrial Pharmacist post graduated in Quality System Management (QSM), she has more than 10 years experience in human and veterinary medicine industries developing new production lines and developing/registering products. For over 20 years she has been working as a regulatory affairs consultant for medical devices, medicines, cosmetics, cleaning products and food companies, having built a solid relationship with regulatory authorities such as ANVISA and the Agricultural Health Ministry. Through her career, her main focus was on Good Manufacturing Practices implementation and audits. Maike has worked with hundreds of companies globally and she brings extensive experience on GMP and in loco audits.

LATEST NEWS

07/18/2024
  From June 24 to 28, ANVISA participated in the MDSAP Forum and Regulatory Authority Council (RAC) meeting in Essen, Germany. The event gathered representatives from 27 countries, including regulatory authorities, MDSAP auditing organizations, and industry representatives, with notable attendance from Brazilian associations ABIMED and [...]
07/02/2024
  In force since January 2022, RDC 591/2021, which provides for the Unique Device Identification (UDI) system, was amended by ANVISA just days before the deadline for attributing and affixing UDI to risk class IV devices. The amendment was published in RDC 884/2024 on June 1, 2024, and is already in force. According to ANVISA,... Leia [...]
04/12/2024
Marking a significant advancement in regulatory reliance mechanisms, the National Health Surveillance Agency (ANVISA) published Normative Instruction (IN) 290/2024, on April 8, 2024. This normative introduces an optimized procedure for evaluating and deciding on registration petitions for medical devices previously regulated in recognized [...]
03/22/2024
Important Regulatory Update for Manufacturers under MDSAP in Brazil Today, ANVISA has announced a significant regulatory development with the publication of Resolution RDC 850/2024. This regulation brings forth a crucial amendment concerning the validity period of the Brazilian Good Manufacturing Practices (BGMP) Certificate for manufacturers [...]
01/05/2024
Collegiate Board Resolution (RDC) 837/2023, published by ANVISA on December 15th, 2023, brings updates to the rules regarding clinical investigations with medical devices performed in Brazil. Effective immediately from the publication, this resolution aligns Brazilian practices with international standards, providing clearer guidelines for [...]
12/13/2023
On 11 of December 2023, ANVISA published Collegiate Board Resolution – RDC 830/2023, addressing risk classification, registration procedures, as well as labeling requirements and instructions for use of in vitro diagnostic medical devices (IVDs) in Brazil. The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates [...]
11/28/2023
Public Consultation No. 1.208 will be open to receive contributions until December 9th. In the dynamic landscape of medical device regulations in Brazil, obtaining the Brazilian Good Manufacturing Practices (BGMP) certification is a mandatory request for manufacturers of Class III and Class IV devices seeking Registro. In a recent move towards [...]
03/01/2023
  Starting today – March 1st 2023 – the new Resolution RDC nº 751/2022  comes into force. The Resolution provides for risk classification, Notification and Registro processes, and the requirements for medical devices’ labeling and instructions for use. In order to meet the new requirements and procedures, ANVISA has already [...]
09/22/2022
The Collegiate Board Resolution – RDC 751/2022 was published on the 21st of September 2022, which provides for risk classification, Notification and Registro processes, and the requirements for medical devices’ labeling and instructions for use. The new RDC consolidates the risk classification and regularization regimes for all risk [...]