CONSULTING

LASEResources provides consulting and contract services for domestic and international customers on a variety of laser and laser-based projects including: 

  • Research, design and development of Center for Devices and Radiological Health (CDRH) certified lasers, laser-based products, automated processes, robotic cells and enclosures

     

  • Regulatory and safety support for laser product compliance per Federal Laser Product Performance Standards 21CFR1040.10 & 21CFR1040.11, EN 207 & 208, IEC-60825, IEC-60601-2-22, ITAR, MIL-STD

     

  • Due diligence research, quantitative laser hazard analysis of radiation fields, accident/incident investigations, white papers

     

  • Testing & labeling of laser products

     

  • Workplace laser safety program development, employee training and ANSI compliant audits

     

  • R&D, engineering, application and regulatory compliance support for manufacturers of laser and light-based medical devices and ancillary instrumentation

     

  • R&D, clinical application, regulatory compliance and monitoring support for preclinical research and FDA approved Phase II & Phase III multi-center clinical trials of medical lasers, and light-based instrumentation

     

  • Regulatory compliance, safety and monitoring support for Investigational New Devices (IND), Investigational New Drugs (IND), New Drug Application (NDA), 510(k) premarket submissions, Premarket approval (PMA) compliance and quantitative analysis of adverse patient/treatment outcomes and/or events

Note: Laser consulting projects are supported by board certified laser safety officers (CLSO)