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.
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.
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.
Zimmer and Peacock is an ISO13485 contract developer and manufacture and RAQA consultancy, we are unique in our ability to consult on RAQA as QMS is not theoretical to us at ZP rather it is something we do as part of our every day operations. In the adjacent image we show our workflow for raising deviations and non-conformities when manufacturing a medical device/diagnostic. if ZP can consult to you on our expertise in QMS and RAQA please don't hesitate to contact us.