Consultants for the regulated medical device industry
USFDA, European Union, and other countries
Consultants for the regulated medical device industry
USFDA, European Union, and other countries
About Us
Albert Rego, PhD.
Rogelio C. Rodriguez, MS
Daniel B. Rego, PhD.
Principle
Regulatory Affairs and
Quality Assurance
Daniel B. Rego, PhD.
Rogelio C. Rodriguez, MS
Daniel B. Rego, PhD.
Associate
Regulatory Affairs and
Quality Assurance
Rogelio C. Rodriguez, MS
Rogelio C. Rodriguez, MS
Rogelio C. Rodriguez, MS
Associate
Regulatory Affairs and
Quality Assurance
Noha Mikati, BS
Rogelio C. Rodriguez, MS
Rogelio C. Rodriguez, MS
Project Manager and
Client Relations
Regulatory Affairs and
Quality Assurance
What We Do
Quality Systems
Technical Expertise
Regulatory Affairs
Establish and manage Quality Management Systems that are ISO, FDA, MDR (EU) and MDSAP compliant.
Regulatory Affairs
Technical Expertise
Regulatory Affairs
Medical device registrations, reporting, and support for US FDA, EU (CE Mark), and other international specific regulations and requirements.
Technical Expertise
Technical Expertise
Technical Expertise
Preparation of technical files, development of protocols and reports, technical assessments, position and white papers, gap analyses.
