The various European Directives for Medical Devices tell the manufacturers to assess the risk for the user and the patient, associated with the use of the device. Furthermore, a good risk analysis will accelerate the development process, will provide useful information with respect to the manufacturing process and quality control, and will be a valuable source of information for troubleshooting, customer services, etc.
Experience has taught us that it is not easy to carry out risk analysis in a company:
This all leads to a lengthy process and unsatisfactory results.
Qarad’s Roadmap leads you stepwise through the process, providing structure and guidance along the way.
The end result is a risk analysis report, which is:
Because of these characteristics, a risk analysis report and its supporting documentation are highly transparent and easily recognizable to auditors and other readers.
Manual, containing brief explanation of the general principles of FMEA explanation of the principles of Qarad’s Roadmap.
Step-by-step guidance to carry out the risk analysis templates for:
CD-ROM, containing electronic versions of templates for:
Qarad can provide training on risk management and risk assessment, using the Qarad Roadmap, or provide assistance by e-mail or telephone. Ask for prices.
Qarad’s risk analyses of HIV, HCV, HLA, other assays and of medical devices have been assessed by a Notified Body and found to be meeting the regulatory requirements.
EN ISO 14971: Medical Devices - Application of risk management to medical devices.