M e n t o r
Documents and Consulting
21 CFR 820 and ISO 13485:2016 Quality Systems Management
-
Audit Preparation, Internal Auditing
-
Regulatory Compliance
-
Project Management
-
Quality Assurance
-
Quality Control
-
21CFR 820
-
ISO 13485: 2016
-
Validation Engineering
-
Disparity Studies
-
Computer Systems Assurance
-
IT Systems Validation
-
Data Analytics
-
FDA Remediation Projects
-
GMP, GLP, GDP, GxP
-
21CFR parts 210, 211
-
CAPA
-
Deviation Management
-
Training
-
COFEPRIS Compliance
-
Audit Hosting
Mentor Documents and Consulting offers your organization:
A recently retired FDA Inspector, Vice President Gilbert Valdez.
Our President and Vice President have combined 50 years’ experience
Our staff includes PhD Executives with expertise in clinical trials, remediation and project management.
-
Medical Device
-
Biotechnology
-
Pharmaceutical
-
General Manufacturing
-
Quality and Compliance
-
Disparity Studies
-
Data Analytics
Expert 510(K) Submissions GUDID UDI Labeling Compliance
Our Certifications
Proudly Serving Texas, the USA and Mexico with offices in San Antonio.
how can we help you grow and improve?
📞(210) 236-1764