ZP is an ISO13485 contract developer and manufacturer of biosensors and IVDs, as part of our complete service offering we provide Regulatory Affairs and Quality Assurance consulting, either in conjunction with our contract development and manufacturing services or independent of our other services.
In the adjacent video we discuss the costs of bringing IVDs to market, and the impact of the 510k route versus the PMA route.
ZP is able to guide clients through their PMA and/or 510k journey including strategizing on the regulatory pathway.
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.
Zimmer and Peacock is an ISO13485 company, certified for the manufacture of electrochemical biosensors and in-vitro diagnostics.