External Development | Surgical Implants & Instruments
Device Validation | Surgical Implant and Instrument portfolio
The Brief:
Working with internal Quality and Regulatory department, we were tasked to lead and execute design verification and validation activates relating to a surgical portfolio of 46 implants and 56 instruments.
Project Development:
Using legacy technical files and design specifications, IDE8 conducted remediation testing activities relating to all products within the clients portfolio.
From technical updates, to test plan creation and execution. We worked internally within the client's quality management system to complete and update over 100 technical files.
While liasing with external notified bodies to ensure the highest level of product quality was maintained throughout the six month project.
Project Outcomes:
Completion of all engineering activities relating to technical file updates for regulatory submission.
What the Client Said:
" A high-quality output produced to an very aggressive and challenging timeline, highly recommend David and the team."