As of November 2020, ZP is an ISO13485 certified company for the manufacturing of biosensors, IVDs and MDs.
This means that ZP is able to document and control our clients contract development and manufacturing, within an ISO13485 framework of documents, procedures, requirements and work-orders. ZP supports clients through their CE marking and FDA submissions. This includes, but not limited to, creating the technical file for the products, establishing and maintaining the PHR, DHF and DHR, conducting and reporting the performance evaluation studies for IVDs, literature reviews and data processing for clinical evaluation of MDs. All documents and records are subject to our QMS documents control and change control procedures.
If you have any questions for ZP regarding our ISO13485 framework for biosensor, IVD and MD contract development and manufacturing, please don't hesitate to contact us.
ZP has a very specific Standard Operating Procedure for on-boarding clients into our QMS system. If you are intending to use ZP products or services as part of a medical device or medical diagnostic then please contact us requesting that you would like to discuss ZP-SOP-2020-0159.