Eagle Medical is proud to announce:
This innovative offering will dramatically reduce your time to market while ensuring your device packaging will protect your product and comply with international standards and requirements.
How does PATH™ compare?
FDA Master File
Submission-ready data set
Package design / material inventory
Package validation (distribution)
Sealer Process validation (IQ/OQ/PQ)
Accelerated aging, 1 year
Accelerated aging, 5 year
Real-time aging
Human factors evaluation
Product Labeling
Standard Package Development
6 – 9 months
N/A
5 – 6 weeks
4 – 24 weeks
3 – 5 weeks
4 – 6 weeks
6 - 8 weeks
20 – 22 weeks
Required
4 – 5 weeks
2 weeks
“Pre-validated”
3 - 4 months
No
Some data provided
3 - 4 weeks
Required
2 weeks
True-Validated™
3 weeks
Complete Data Set
Required
Find out how PATH™ eliminates the need to source materials, design/build/test packaging, and validate processes.
