Showing 19–27 of 32 results
-
£150.00
This document will help you understand the definition of SaMD under the 1993 Medical Device Directive as well as the 2017 Medical Device Regulation, how to classify your software and which conformity route to take in order to become complaint with the new MDR.
A preview of the Guidance for EU MDR Software as a Medical Device (SaMD) is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
-
£100.00
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.
-
£60.00
The basis of the validation is to prove the anaerobic conditions are maintained by circulating the anaerobic gases such as CO2, H2Â and N2 in addition to thermal mapping to identify risk to product that may be exposed to temperature that is unsuitable for its state and composition.
-
£60.00
The IOQ (Installation Operational and Qualification) for Incubator Validation is to ensure that the Incubator has been installed in accordance with manufacturer’s specifications and operates correctly and is fit for use in accordance with cGLP, Health and Safety requirements and user requirements.
-
£1,000.00
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.
-
£100.00
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.
-
£200.00
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.
-
£60.00
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.
-
£100.00
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.
