FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994 Preparation of (as necessary): 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. Institute the Quality System: 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. Validate the: 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).      Home | CEO Profile | Philosophy | Contact Us      Educate | Implement | Attain | Maintain | Audit | Improve CONTACT QUALITY AND REGULATORY SERVICES, INC. Tel: 925-787-2421 Email: © Copyright 1998-2011. All Rights Reserved. Quality and Regulatory Services Inc.