Interfaces with subcontractors, contract manufacturers, etc.
Many medical device companies have subcontractors, contract manufacturers, project partners and/or sister divisions contributing to the development of a medical device. Our SOP’s provide solutions for the control and approval of technical and quality information flowing between these entities. For example, FDA is very concerned about changes made by vendors which are not transmitted to the customer company for approval. Our medical device SOP's consider information transmiited to and from project partners and will maintain your company in FDA compliance.
Simplified change control for pre release, comprehensive control for post release
We offer two design change control SOP’s: pre-release and post-release. The Post-release change control SOP is much more stringent because of the high costs and additional safety, quality and business risks associated with changes occurring during medical device manufacturing. The pre-release design change control SOP allows Engineering to have quick reaction time while providing adequate control. This approach has been found to be efficient and well liked by Engineering Departments.
Click on "SOP's Available" to see descriptions of the SOP's available for sale