Medical device companies need to establish a Quality System to meet regulatory requirements. CQ has a proven track record in developing Quality Systems to meet FDA scrutiny and obtain ISO 13485 certification.
CQ can build your Quality System from scratch. We can also work with your existing procedures to help you ensure compliance. We’ve been through FDA Quality System inspections and ISO certification audits. We know what these inspectors expect in a medical device Quality System.
Here are ways our Quality System services can help:
- Ensure compliance with FDA 21 CFR part 820 Quality System regulations.
- Ensure compliance with ISO 13485:2003 Quality System requirements.
- Conduct Quality System “gap analysis” against FDA / ISO.
- Draft and implement procedures, forms, templates.
- Provide Quality System training.
- Conduct internal auditing for your company.
- Audit and assess effectiveness of quality system procedures, thus ensuring FDA and ISO compliance.