FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994

Orientation sessions for Management with Executive Responsibility:
  • 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.
Education and Training for all personnel:
  • 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).

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