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Medical Device Regulatory Affairs . Consulting and Management

We are a consulting company specialized in Medical Device Regulatory Affairs, formed by a multidisciplinary team of professionals with over 20 years of experience in the public and private sector.
We provide consulting services on a national an international scale, streamlining the access to new markets with custom solutions according to your company´s needs.
Our services are focused on Latin American countries: Argentina, Brazil, Mexico, Colombia, Ecuador, among others.
The scope of our services extends to Europe and United States

Our main services:
– Centralized coordination and regional management of Regulatory Affairs
– Medical device registration
– Specialized technical translations
– Facility design
– Quality management
– Internal and external audits
– Online project control

Company’s Keywords:

consultancy, regulatory affairs, regulatory affairs & consultancy

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