Shelf Life – Accelerated Aging and Real Time
£100.00A recommended template which will guide you through the regulatory requirements to fulfil your claims.
Showing 28–32 of 32 results
-
-
Software as Medical Device Start-Up Template Package
£2,200.00If you are a start-up company developing an app or health software that could have an intended medical purpose, then you will need to consider the adoption of the recognized standard for Medical Device Software EN 62304: 2006+A1: 2015. The standard guides you to output a number of documents that can be used as Verification and Validation of the software in preparation for submission to the notified bodies or the FDA etc.
Pharmi Med has prepared these templates to help start-up companies who traditionally do not have Medical Device experience but usually from a Software Engineering background but need to penetrate the market. We have reduced the burden by creating these templates for your engineers. If you need further assistance in the regulatory framework of submissions please contact us here
You can preview the document below:
You may purchase the full package including instructions for use below.
-
Test Method Validation Report
£40.00Once the test method protocol is completed and documented, a test method validation report is required to interpret the results of the criteria stated in the test method validation protocol.
-
UDI Template (MDR)
£60.00The new European medical device regulations, EU MDR 2017/745, have introduced the Unique Device Identification (UDI) system as a requirement for medical device products that are to be sold in the European markets. Medical devices will need to be assigned a UDI number which will be linked to a UDI database.
The aim of this template is to illustrate the UDI system to manufacturers of medical devices and define its obligations regarding the UDI system and UDI number on their products.
A preview of the UDI Template (MDR) is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
-
Usability Checklist
£40.00The usability checklist is intended to obtain suitable usability of the medical device, by minimising the error and the risk related to the use of the device that are able to be amendable by the manufacturer.