Device Development and Cold Chain 

Lucidyne has consultants that keep in track of latest industry changes.   We have people with experience in device development, combination products, and cold chain.  Our staff has experience in process and design risk assessments, and qualification of products and how they get delivered to the customer.  The following are examples of documents that we have worked on to get the equipment qualified:

• URS

• Device and Equipment Specifications

• Design Specifications

• Project Plans

• Qualification Protocols

• Operational and Performance Qualifications (dynamic and static)

• Testing in international countries, working with Logistics and Global Air Freight

• ASTM Testing

• Thermal Profile Development for global itineraries