FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994
Preparation of (as necessary):
Institute the Quality System:
- Registration of manufacturer with the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
- Preparation of clinical research protocol and Investigational Device Exemption (IDE) submission.
- Premarket Approval (PMA) application.
- Premarket Notification [510(k)] submission.
- Submissions to meet the CDRH Radiation Health regulation requirements for medical devices emitting electronic product radiation (x-ray, laser, video monitor, ultrasound, micowave, rf).
- Response to FDA 483 and/or Warning Letter.
- Educate and train employees on the quality policy, procedures and work instructions.
- Apply the quality policy, procedures and work instructions.
- Frequent review of quality records produced to document compliance with the quality system.
- Audit compliance with quality policy, procedures and work instructions.
- Revision of quality policy, procedures and work instructions to comply with actual practice and the CDRH/FDA Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), requirements and ISO 13485 requirements.
- Design of the medical device(s).
- Software used in manufacturing and/or to comply with other requirements of the CDRH/FDA regulations and ISO 13485 Quality System standards.
- Processes and software used in the manufacture of the medical device(s).
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