We Get You Across the Finish Line!

We provide the services you need to get your medical device “across the finish line.” We fill-in gaps and provide engineering, project management, quality and regulatory services to help you release your product for commercial sale or get into the clinic for clinical study. We don’t just “advise” you – we can prepare needed testing and paperwork FOR you in a hands-on way.

 

What We Do

What We Don’t Do

  • We get you compliant and ready to launch your medical device into the market or the clinic.

  • Provide Expert Project Management in support of your goals.

  • Create your entire Design History File for you.

  • Plan your Design Verification and Validation Testing for you, conduct it, and write the needed reports for you.

  • Create the documentation you need to submit for regulatory approvals including FDA 510(k).

  • Train you how to perform any needed Risk Analysis.

  • Perform your Risk Analysis for you, with you as a participant.

  • Create your Risk Management File for you in a manner that is compliant with ISO 14971

  • Create your Usability File for you in a way that is compliant with ISO 62366.  We can also manage all needed usability testing to help you ensure compliance with this standard.

  • Manage the entire process for achieving ISO 60601-1 3rd Edition approval for you.

  • Help you solve YOUR Medical Device Product Development problems in a HANDS-ON way.

  • We don’t design products.  We are not an industrial design or design engineering firm.  However, we partner; work hand-in-hand with; and support you, and your design firm.  We can also help you select a design firm if you need one.  We partner with many of the leading design firms.  We can guide you in making the right choices for your medical device.

  • We are not a contract manufacturer – However, we partner with leading contract manufacturers.  We can guide you in your selection of the right contract manufacturer for you.  We can also guide you and assist you in a smooth transition of your product into production.

  • We do not specialize in medical device software.  However we partner with experts in this  field.  We can guide you in making the right choice for you.

  • We are not a test lab.  We have only very limited in-house testing capability.   However we partner with many leading labs.  We can guide you in making the right choice for you.