Risk Management for Medical Devices and In-Vitro Diagnostic Medical Devices


Risk Analysis or Risk Management?

Looking into literature and standards You can find two different approaches for risk evaluation for Medical Devices and IvD Devices. On one hand Risk Analysis is discussed on the other hand Risk Management seems to be the only solution.

The difference between the two approaches is historical: Risk Analysis has been used in the past according to the standard EN 1441. The method described in this standard is now included in Risk Management according to the international standard ISO 14971.

This actual standard is dedicated to be used as part of the conformity assessment for CE-marking and FDA-Submissions for Medical Devices and IvD Devices.

Conformity to the Essential Requirements using Risk Management

The Technical Documentation of the devices according to the annexes of the Directives 93/42/EEC and 98/79/EC demands the results of the Risk Management as part of the Product File. A descriptions of the solutions adopted to meet the Essential Requirements of the Directives should be included as well. This so called EC-Checklist could be realized very easily having a clever made Risk Management File.

A good and complete Risk Management File is nearly half of the Technical Product File. consulting & more will support You in implementation of the philosophy and method of Risk Management in Your company.

Risk Management included in the design process reduces "Time to Market"!

According to the standard ISO 14971 Risk Management Process should be run parallel to the product design. This can shorten the double work and the communication expenditure in the different phases of the product development - especially when two or more developers share the same project.

consulting & more can develop together with Your R&D-Department Your individual Risk Management Process even if You need a design process spreading over different departments or companies. Take Your benefit in our experience working in worldwide design projects for years.

The method of Risk Management is not only limited on the device development. It fits as well in process optimization and validation which can be simplified and systemized by Risk Management method. consulting & more can support Your company on Your way to implement an effective and accepted procedure. Tell us Your requirements between Validation Master Plan and Global Harmonization Task Force and we will lead to realization.