Medical Device Packaging 101: From Prototype to Validation

Medical device packaging is a critical part of product safety and regulatory compliance. Here is a clear overview of the full process from early concept to validated production packaging.

1. Define Regulatory & Use Requirements

Device class & regulatory pathway
Sterilization method (ETO, Gamma, e-beam)
Storage & transportation environment
Clinical vs. home use

2. Choose the Packaging System

Pouch + backer card
Thermoformed tray + Tyvek
Kit configurations

3. Prototype & Form-Fit-Function Testing

Device security & immobilization
Aseptic presentation
Labeling and IFU integration

4. Plan Validation

Accelerated aging
Transit simulation (ISTA / ASTM)
Seal integrity & strength testing
Sampling plans

5. Documentation Requirements

Specifications & drawings
Supplier qualifications
Validation reports
Inspection criteria

Need Help?

Influence Packaging supports medical device teams with strategy, structure, supplier selection, and validation planning.