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.

Here are some examples of our recent work:

 

 

 

 

 

 

Just Some of our Most Recent Projects

  • Created design history file for new laparoscopic surgical instrument.  Conducted all design verification and design validation testing.  Wrote 510(k) submission for this device, and achieved approval.  Executed manufacturing transfer for this device including equipment IQ/OQ and PQ and overall manufacturing process validation.

  • Created design verification test plan for new bio-absorbable orthopedic surgical implant.

  • Created retrospective design history file for a legacy product which experienced regulatory challenges due to the fact that its documentation was not up to the latest standards.  Identified gaps in the design history file, and performed the testing needed to fill those gaps.

  • Augmented design team for new ophthalmic-related product family.   Created risk management file.  Planned and executed design verification tests including biocompatibility testing, package validation, and sterilization validation (EO).   Participated in design reviews as independent reviewer.

  • Authored complete Quality System  for start-up company (in home, diagnostic product).

  • Authored Quality System for a start-up company (doctor’s office, diagnostic product).   Helped company secure FDA approval for this class II device.

  • Represented clients in Audits including regulatory agency, notified-body audits, and independently executed internal audits.

  • Created new Risk Management Procedure and Usability Engineering Procedure for drug infusion pump company.

  • Created Risk Management File and Usability File, and completed all paperwork for submission for IEC 60601-1 3rd Edition approval.

  • Significantly revised Risk Management Procedure and created new Usability Engineering procedure; revised Risk Management File and created Usability file for an ophthalmic-related therapeutic device.  Successfully achieved 60601-1 3rd edition approval.

  • Investigated and solved technical problem with  on-the-market ophthalmic surgical  device for manufacturer.  Performed  engineering characterization of the device, performed  root-cause analysis, recreated problem and recommend the solution.