Imagine the development of a new medical device in which you work directly with your plastics supplier to establish your specific material needs. A custom compound is developed using known biocompatible materials, focusing on your requirements for color and functionality, all while using the most cost effective raw materials. At RTP Company we have not only imagined this scenario, we make it a reality everyday.
Based on decades of experience, RTP Company’s engineers will formulate a custom compound ideally suited for your medical device. Our engineers select materials from our database of base resins, pigments, dyes, lubricants, reinforcements and a variety of other additives that have successfully passed biocompatibility testing. This allows us to create plastic compounds with confidence that you will pass your ISO prescribed biocompatibility testing requirements.
Formulation Control
We also understand the need to maintain control of the materials in your custom formulation in order to preserve the testing integrity of your finished molded and assembled device. For these situations, RTP Company has established a No Substitution policy which is applicable when requested by the customer at the beginning of the formulation process. Using our ISO 9001 quality system procedure, we can ensure your custom formulation is maintained by using a specific nomenclature that signifies that no raw material changes or substitutions are allowed unless authorized.
Change Management
Should a need to change your custom formulation occur, the following steps are taken:
- Notify you of the change as soon as detected
- Provide you with information regarding the type of change
- Provide you with timing on the change
- Provide you with options to manage the change
This No Substitutions service provides an additional layer of protection to your custom formulation to help ensure that the product you specified and qualified is the same product you get on each order.
