At ZP we have an ISO 13485 Quality Management System (QMS) highly tuned to the development and manufacturing of electrochemical biosensors and in-vitro diagnostics. Therefore all the templates on this page are tuned towards these types of products.
Note a download link to the document will be provided shortly after payment is received. Please note ZP can provide a consulting service to clients who wish to discuss the filling out of these documents after purchase.
The System Requirements Specification Template is a document that described the product requirements
The Risk Analysis is is a document that describes the risks associated with a product and helps evaluate those risks.