FAQs

1) I have an idea for a medical device. Can Phase II turn this concept into engineering prints and a product?
YES, Phase II is highly experienced in developing, or assisting in the development of, medical devices from an idea to a final concept.

2) What is the average product turn-around time?
a) If design is involved, there is no average. Each device must have all necessary steps fulfilled before production can begin.
b) If design is already complete, but it is Phase II's first time assembling your product, manufacturing processes and equipment will need to be prepared, checked, and validated before production begins. These activities usually take 1-6 months, but are dependent on device- and customer-specific requirements.
c) If design is already complete, Phase II has previously built your product, and no major changes have been made since your last order, turn-around time is usually 8 weeks or less from our receipt of the order. This allows time to obtain components, if necessary; assemble, test, and pack devices; and have the product sterilized and/or shipped to the desired location.

3) Do I have to obtain CE-marks for products I want to distribute in the European Union - or a Medical Device License for products I want to distribute in Canada - or can Phase II do it for me?
We understand that some companies may not have the structure, knowledge, or desire to go through the process(es) of meeting international requirements. Phase II is already represented in the European Union and established as a manufacturer in Canada: our staff can help you obtain CE-marks and Licenses for your product, or do it for you.