| time-to-market |
 |
Comprehensive line of 510(k) registered medical devices |
| |
Technical dossier assistance to support customer
CE Mark application |
|
Concept development prototyping |
|
Dock-to-stock supply chain management |
|
| |
| development |
|
Product, packaging, process design & scale-up |
|
Physician advisory |
|
Pre-clinical studies |
|
Project Management Professional (PMP) certified Project Managers available to manage development from concept through commercialization |
|
Validation Engineering Test Lab, DOE, Reliability Analysis, Gage R&R, SPC, Clinically Relevant Testing |
|
ASTM & ISTA distribution compliance testing |
|
|
| full regulatory capabilities |
|
510(k) |
|
Design History File compilation |
|
Device History File management |
|
CE Mark |
|
Technical dossiers |
|
PMA support |
|
Clinical complaint management and analysis |
|
Established design control process |
|
| |
| quality |
|
Nearly 50 years of medical device experience |
|
FDA, QSR, ISO 13485 |
|
Japanese PMDA compliant for device design & manufacturing |
|
|
|
|
