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This template gives guidelines to the manufacturer in order to assign correctly the UDI on the device and the UDI database and hence successfully place the device on the market.
A preview of the Unique Device Identifier (UDI) Plan and Report is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
Download our complete MDR package with checklists/ gap assessments, guidance documents and templates to the new EU MDR.
A preview of the MDR Complete Package is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This template includes all the requirements of the procedures of PMS and PSUR by giving descriptions and any necessary information required from the regulation MDR 2017/745.
A preview of the Periodic Survey Update Report is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This document aims through infographics and examples to give guidelines to the manufacturer to understand and familiarise his obligations according to PMS, PSUR and PMCF.
A preview of the PMS Gap Assessment is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This template is designed to give guidelines to the manufacturer in order to produce a successful PMCF plan and report which meets the regulation MDR 2017/745.
A preview of the Post Market Clinical Follow Up Plan and Report is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The Quality Assurance plan includes the documentation of the project quality, the responsibilities of the quality activities, regulatory approvals, inspections and test activities and ensuring whether the acceptance criteria have been met.
A recommended template which will guide you through the regulatory requirements to fulfil your claims.
If 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.
The 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.