Scroll
Avoid a rejection, an audit finding or a missed deadline.
We support manufacturers, importers, and medtech startups with medical device registration and keeping their quality management systems up to date with ANMAT, ANVISA, INVIMA, COFEPRIS, the FDA, and other international regulatory agencies.
One team, with offices in Argentina, Brazil, and the U.S.
We take part in regional regulatory forums (advising CAEHFA, MERCOSUR GT11, IMDRF) and explain what is changing and when it affects you.
Services for your Company
Every service has a defined deliverable, timeline and price. Start with a diagnostic and move forward only if it makes sense.
Turnkey QA/RA subscription
Turnkey QA/RA subscription
- Regulatory calendar with expiry alerts
- Registrations and renewals before ANMAT, FDA, ANVISA and COFEPRIS
- Document updates and change management
- Quality system implementation and internal audits (ISO 13485)
- Post-market surveillance
- Monthly report: what was done, what is due and what the risks are
- Free Sales Certificate and CE marking (MDR), when the project requires it
- Coordination of laboratory testing against the applicable standards
FDA Readiness Check and Gap Analysis
FDA Readiness Check and Gap Analysis
- Regulatory Affairs Inteligence
- Global Healthcare Project Management
- Regulatory Hosting in the Americas
- Internalization and Development of New Markets
- Regulatory Assessment of International Manufacturing Plants
- Regulatory Analysis of New Products, and Inspection of Manufacturing and Processes
- Assessment of Suppliers and New Medical Products for Commercial Portfolio
Medical Technologies Development
Medical Technologies Development
- Documentation and design
- Determination of usability and applicable
- Product Master Register
- Risk Analysis
- Validations
- Clinical and preclinical trials
- Market analysis
Our Featured Clients
Here are some of the companies Mc Coubrey has empowered to forge ahead with their objetives.
Serving as a compass that guides our actions and defines our behavior
We bridge the gap between national agencies, medical technology, risks and advisory services ensuring safety and growing together.
How We Do it.
1. Understand
In our Discovery meetings we care deeply to understand our clients requriments and problems to help them go trough with powerful stretagies.
2. Plan
Our specialized team create particular projects plans and proposals based on customer’s special needs.
3. Act.
Upgrade your team with increased autonomy with an empowered workforce that puts you on the growth.
FDA Approval Process
Fill the form to contact Us
Send Technical Requirements
Agreement and budgets
Submit the information to FDA
Meet Our Team of Experts
Our core principle was to invest in people, communities, and the success of our clients
Featured News and Events
We participate of best internationals medical devices fairs to understand market needs staying always updated of new technologies. Let´s arrange a meeting there!
Our World Offices
Strategically located, our offices meet specific regulatory requirements for every project.
Miami, Florida US
MC COUBREY GROUP LLC
21500 Biscayne Boulevard, Suite 401 Aventura,
33180 Florida (FL)
Working Hours: 07am to 5pm
Buenos Aires, Argentina
TRISKEL SOLUCIONES
Perú 345 , Piso 12
Ciudad Autónoma de Buenos Aires (CABA)
Working Hours: 07am to 5pm
Santa Catarina, Brazil
GLOBAL BUSINESS SERVICES
Rua Antônio José de Aquino, 407
88210 Porto Belo (SC)
Working Hours: 07am to 5pm
Address Business
Perú 345 , Piso 12
Buenos Aires, (CABA) Argentina
Contact Us
Send mail: info@mccoubreygroup.com
Call us (ARG): +54 911 32650545
Call us (US) : +1 3055283416
Your benefit when contacting us:
Let’s start today
From an early stage start-up’s growth strategies and new technologies development to helping existing medical devices companies, we have done it all! The results speak for themselves. Our services work!