CDRH Product Certification Audit

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P/N
EDU-AUDITC

More Information
Product Name CDRH Product Certification Audit
P/N EDU-AUDITC
Availability - Get Quote -
Course/Service Type Consultation
Topics/Agenda

Kentek will review all Engineering Controls required by CDRH 21CFR1040.10:

  • Protective Housing
  • Remote Interlock Connector
  • Safety Interlocks
  • Key Control
  • Emission Indicator
  • Labeling
  • Beam Attenuator
  • Viewing Windows and Optics
  • User Information
  • Location of Controls

Customer will receive:

  • Laser Hazard Analysis Report for each system design.
  • Recommendations for Engineering Control Compliance Measures.
  • Technical assistance completing CDRH report form FDA 3632 and attachments in order to obtain an accession number.
  • Assistance writing laser safety practices for user manual (if necessary).

Course Duration Custom
Industries Served Laser Integrators, Equipment Manufacturers
venue On-Site Options: Virtual or Kentek staff at your location
Description

The Center for Devices and Radiological Health (CDRH) is a division of the Food and Drug Administration (FDA) and requires that all products containing lasers that are imported or sold in the United States must be certified. U.S. laser manufacturers must report their products to the CDRH for a type of prior approval. These laser product reports are typically 35 to 60 pages in length and require specialized analysis and data. Manufacturers and importers of lasers must also file additional special reports once a year.

Kentek’s Product Certification Auditing services are designed to assist laser manufacturers and integrators in becoming compliant with the CDRH and FDA reporting requirements to help avoid penalties and fines with the sale of lasers in the United States of America.

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