FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994
Orientation sessions for Management with Executive Responsibility:
Education and Training for all personnel:
- Overview of U.S. Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) regulations for Medical Devices.
- Overview of the European Community Medical Device Directive (MDD.)
- Overview of ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes.
- Overview of the requirements to place the CE mark on medical devices.
- CDRH/FDA Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), requirements, Title 21 Code of Federal Regulations Part 820 (21 CFR 820.)
- Premarket Notification [510(k)].
- How to prepare for an ISO 13485 audit by a Notified Body.
- How to prepare for an FDA Inspection.
- Preparation and application of QSR/CGMP standard operating procedures (SOPs).
- How to prepare a submission to the CDRH/FDA.
- How to prepare an Investigational Device Exemption (IDE.)
- How to prepare a Premarket Approval application (PMA.)
- The requirements of the ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes.
- Regulatory requirements for medical devices emitting electronic product radiation (x-ray, laser, video monitor, ultrasound, micowave, rf).
CONTACT QUALITY AND REGULATORY SERVICES, INC.
© Copyright 1998-2011. All Rights Reserved.
Quality and Regulatory Services Inc.