CDRH Product Certification Audit
Product Name | CDRH Product Certification Audit |
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P/N | EDU-AUDITC |
Availability | - Get Quote - |
Course/Service Type | Consultation |
Topics/Agenda | Kentek will review all Engineering Controls required by CDRH 21CFR1040.10:
Customer will receive:
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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. |