JALEX Medical offers custom Quality Management Solutions for any size organization in the medical device industry.
Short on resources for your product launch? JALEX Medical can serve as your quality department as you ramp up production and enter the medical device market. Monthly and on-demand options are available, contact us for additional information.
Quality Management System Solutions
Risk Management Assessment
QMS Gap Analysis Reporting & Implementation
MDSAP Support
Process Validation Consultation & Support
Custom QMS Development
Compliance Auditing
UDI Support and Corporate Training
JALEX Medical Offers
Certified Auditors & Quality Engineering Support
"When a regulatory agency conducts an audit, it can be overwhelming for Clients. You can count on our Quality Engineers to step in with the answers."
Angelica Boucher, CQA
JALEX provides compliance auditing for the following regulations
FDA 21 CFR 820 Quality System Regulation
FDA 21 CFR 1271 Human Cells, Tissues, and Cellular and Tissue - Based Products
FDA 21 CFR 600 Biological Products
ISO 13485 Medical Devices - QMS - Requirements for Regulatory Purposes
