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About Us
Our team
Our history
Our history
Our professional team based philosophy encourages all companies to meet their quality and regulatory requirements around the world.
Our history
Our history
Our history
In 2001, Global Compliance Plus started regulatory and quality assurance consulting. Our clients range from small to large multi-national medical device manufacturer's.
Our mission
Our history
Our mission
Our mission is to provide regulatory and quality solutions that meet medical device manufacturer's global regulatory compliance.
Provided Services
- Design and Implementation of Quality Systems
- Quality System document generation
- Supplier selection and monitoring activities
- Corrective and Preventative action
- Complaint handling
- Post market surveillance activities
- Global regulatory strategy evaluation, design and implementation
- ISO 13485 auditing services
- FDA 21 CFR 820 auditing services
- FDA Registration and listing
- 510(k) Preparation and submission
- US Agent
- FDA Product classification
- Packaging and labeling review
- UDI compliance
- GUDID Third party submitter