The 12 Steps to Market
Melinda
Time to market is a key concern for many manufacturers and there are many factors influencing when a product will be delivered to market. This is especially true when it comes to medical devices, which must comply with strict industry standards to ensure that patient safety is not endangered. We at DDL believe manufacturers can better manage their risk and enhance their chances of delivering their product to market on time and intact by following these 12 steps:
1. Packaging Design Requirement
2. Packaging System Hazard Analysis
3. Labeling Requirements
4. Evaluation of Similar or Competing Devices
5. Understanding the Clinical Application of a Medical Device
6. Distribution, Storage & Handling of the Product
7. Prototyping the Packaging System
8. Stability Testing, Accelerated & Real Time Aging of Sterile Barrier System
9. Sterilization Effects on Biocompatibility & Sterilization Validation, Device & Package
2. Packaging System Hazard Analysis
3. Labeling Requirements
4. Evaluation of Similar or Competing Devices
5. Understanding the Clinical Application of a Medical Device
6. Distribution, Storage & Handling of the Product
7. Prototyping the Packaging System
8. Stability Testing, Accelerated & Real Time Aging of Sterile Barrier System
9. Sterilization Effects on Biocompatibility & Sterilization Validation, Device & Package
10. Integrity of the Sterile Barrier System & Packaging System Performance Testing
11. Packaging Equipment Qualification, IQ and OQ
12. Packaging Process Development & Performance Qualification (PQ)
11. Packaging Equipment Qualification, IQ and OQ
12. Packaging Process Development & Performance Qualification (PQ)
