MEDISI America
Medisi America is a leading consultancy specializing in medical device regulation and market entry in Latin America and the USA. Since 1980, they have been committed to excellence, providing timely, ethical, and business-oriented solutions to help clients navigate complex regulatory environments and achieve their international goals.
Industries
Nr. of Employees
small (1-50)
MEDISI America
Mexico City, Distrito Federal, Mexico, North America
Products
Regulatory Services
Professional regulatory consulting and medical device registration services for market access.
Quality Assurance
Quality assurance consulting and compliance services for medical device companies.
Training
Specialized training programs for regulatory affairs and quality assurance in the medical device industry.
Regulatory Services
Professional regulatory consulting and medical device registration services for market access.
Quality Assurance
Quality assurance consulting and compliance services for medical device companies.
Training
Specialized training programs for regulatory affairs and quality assurance in the medical device industry.
Services
Act as the local legal holder or authorized representative to enable product registration and distribution in target Latin American markets without the manufacturer establishing a local office.
Regulatory submission support, dossier preparation, and interactions with Mexico's regulatory authority for medical device registration and approvals.
Regulatory submission support, dossier preparation, and interactions with Brazil's regulatory authority for medical device registration and approvals.
Regulatory submission support and market entry assistance for Colombia's regulatory environment.
Interpretation and adaptation of international GMP and quality system requirements to the documentation and practices expected by local regulatory authorities.
Monitoring of regulatory authority reorganizations, audit outcomes, and changes in submission criteria to update strategy and expectations for clients.
Act as the local legal holder or authorized representative to enable product registration and distribution in target Latin American markets without the manufacturer establishing a local office.
Regulatory submission support, dossier preparation, and interactions with Mexico's regulatory authority for medical device registration and approvals.
Regulatory submission support, dossier preparation, and interactions with Brazil's regulatory authority for medical device registration and approvals.
Regulatory submission support and market entry assistance for Colombia's regulatory environment.
Interpretation and adaptation of international GMP and quality system requirements to the documentation and practices expected by local regulatory authorities.
Monitoring of regulatory authority reorganizations, audit outcomes, and changes in submission criteria to update strategy and expectations for clients.
Expertise Areas
- Medical device regulatory affairs
- Latin America market access and registration
- Local representation and legal holder services
- GMP and quality systems translation for local compliance
Key Technologies
- Local market authorization processes (COFEPRIS/ANVISA/INVIMA)
- GMP compliance frameworks
- Regulatory submission documentation and workflows
- Regulatory intelligence and monitoring (policy tracking)
News & Updates
A recent update on the evolution of COFEPRIS and its impact on the regulatory landscape in Mexico.
FDA's designation of a Class I recall for certain ResMed ventilators due to safety concerns.
Development of a nuclear medicine technique for personalized cancer treatment.
Research suggests that deep brain stimulation can benefit patients with severe depression.
A study indicates potential mislabeling in FDA adverse event reports involving certain medical devices.
Deep-learning algorithms outperform human evaluation in detecting lung cancer from scans.
A recent update on the evolution of COFEPRIS and its impact on the regulatory landscape in Mexico.
FDA's designation of a Class I recall for certain ResMed ventilators due to safety concerns.
Development of a nuclear medicine technique for personalized cancer treatment.
Research suggests that deep brain stimulation can benefit patients with severe depression.
A study indicates potential mislabeling in FDA adverse event reports involving certain medical devices.
Deep-learning algorithms outperform human evaluation in detecting lung cancer from scans.