We have the best specialists in Medical Product Regulation
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The Passarini is a Group that pursuits excellence in the provision of services(Regularize licenses from Ansiva, INMETRO and more) in the Regulatory Assistance and Consulting.
Our goal is provide a quality service for your company, always looking for improve our internal processes, guaranteeing an effective management of the services we offer. Do your Regularize licenses from Anvisa, Anatel, INMETRO and more.
We have the commitment with the quality and we seek a continuous updating, with the major goal to increase our clients’ satisfaction.
What our customers say:
A&D Medical has entered the Brazilian market with our blood pressure monitors. Passarini managed our registrations and helped us through the complexities of the regulatory environment in Brazil. We’ve enjoyed working with Passarini due to their knowledge of the regulatory requirements and their ability to manage all the unique steps in the process, including ANATEL, INMETRO and ANVISA.
We were having a problem with registering our products on Anvisa, Passarini Group helped us prepare the required documents with a simple direction.
We wanted toenhance our experience to pursue FDA certification. We received training in good practices for project management from Passarini Group and they showed a lot of competence and knowledge about the requirements associated with the processes for FDA certification.
Passarini is a very competent company, after we started using Passarini’s services, our processes for regulating the company and products with government agencies began to process quickly and with the required quality.
I have been working with Passarini for about 10 years, we have always been successful in all processes. A very serious company, reliable and with great service.
We saw Passarini consulting grow, becoming a solid company, today it is a group of companies that have high knowledge in all areas they operate. A Group that grows more and more, adds values, adds employees and serves all companies that need its services with excellence.
We had an issue with the outdated quality system. With Passarini Group´s guidelines, we upgraded to an international standard, even highly praised by the municipal health surveillance. The aspects we like most about the group are seriousness, criticality and transparency. We highlight the support and security on any possible setback with the regulatory sector. We recommend Passarini Group for the security and support provided to us. I’m your fan!
We are the largest company in Brazil in the supply of first aid, surgery, treatment, hygiene and protection items. For more than 86 years, we have been working to care for and watch over the health of all Brazilians. With Passarini Group, contributing and optimizing our processes in such an essential sector, we continue with our objective of taking care of each life.
I’ve followed Passarini’s growth since its foundation, I see the struggle and hard work they’ve done to get here. I currently don’t know of another company in the business whose staff is so attentive and helpful.
In addition to the team that trained us and helped to improve our QMS, Paulo Passarini’s contribution on this journey was of paramount importance, always making himself available to assist us with great promptness. Thanks to the Passarini team.
Together with Passarini we were able to open new business opportunities finalizing our 510K registration.
I recommend Passarini Group for sure, because it really met my expectations, it was a strategic investment to obtain and maintain Derig’s regulatory apparatus.
Congratulations to the Passarini Group for the work it has been doing. The group’s performance has helped the medical device industry in Brazil to achieve good results and to continually improve.
The results that Passarini Group has achieved in several areas, whether national through registrations, CE marking, FDA, among others, demonstrate the group commitment to comply with the projects designated to them.
Our partnership with Passarini started about 8 years ago, with consultancy in ISO 13485 and CE Mark standards. The support of a multidisciplinary team, guiding us to make certain decisions, makes a difference in our processes.
