WHAT WE DO

Gain Consulting Services helps companies - large, small or virtual - get their medical laser/photonics projects going!

SCOPE

We run down everything technical that is needed to get a laser product or medical photonics project going.  Whether it is figuring out how to get the light to a particular target tissue, or where to find a wet lab to do tissue studies, or how to manage an engineering project on a shoestring, we know the technical, engineering and science side of getting your idea off the ground.

SERVICES We Provide

TESTING AND ANALYTIC SERVICES

  • laser and optical radiation safety testing, analysis and reporting for medical laser and medical photonics devices (ANSI Z80.36:2021, ISO 15004-2:2007, ANSI Z136.1, IEC 62471, ANSI/IES RP-27-20, etc.)

  • design and execution of pre-clinical tissue and animal studies for laser and photonics devices

  • design, conduct and reporting of device bench and performance testing of medical laser and medical photonics devices to comply with FDA guidance on bench testing for premarket submissions

  • preparation of publications and scientific presentations, including submissions for peer-reviewed journal publications

DEVICE DEVELOPMENT

  • laser, optical and delivery system design

  • prototype development

  • laser and optical component sourcing

  • budgeting and project planning

  • photonics device test and measurement services

REGULATORY SUPPORT

  • preparation of technical documentation for premarket regulatory submissions to FDA and other regulatory bodies for laser and photonics devices (performed in partnership with medical regulatory consulting firm Regulatory Pathways Group) submi, including:

    • FDA premarket submissions (510(k), PMAs and de novo)

    • IDE and IND drug/device clinical studies

    • IRB studies

    • laser “product reports” and “annual reports” (FDA forms 3632 and 3632 per 21 CFR 1040.10 and 1040.11)

INTELLECTUAL PROPERTY

  • invention disclosures

  • technical writing and analysis for patent drafting

ASSISTANCE WITH FUNDING & INVESTMENT

  • technical due diligence for medical laser and photonics device companies