Successful risk management in IVD ...

... includes all measures for the systematic identification, analysis, assessment, monitoring and control of risks. It is considered an ongoing process in which planning, implementation, monitoring and improvement take place continuously.

... should start BEFORE you start development. By working with your team to define all risks from the start, and then planning to manage them, hence we're able to remove any stumbling blocks at an early stage. This saves you a lot of time and money when it comes to implementing the necessary measures later on.

... Risk management can never stand alone. It is linked to usability, labelling, performance evaluation, PMS. Risk management accompanies development and only ends after the product is no longer available on the market and its durability has expired.

... is our expertise, as our employees have extensive knowledge and many years of experience in the development of in vitro diagnostics and their regulatory requirements.

EN ISO 14971: Application of risk management to medical devices

Both the IVDR and different harmonized standards require a risk management process. EN ISO 14971 describes a process for the “application of risk management to medical devices” including in vitro diagnostics. The standard offers a procedure enabling the manufacturer to identify, assess, and control the risks linked to its device.

No other standard is so closely related to other standards. Give EN ISO 14971 the attention it deserves!
We will be happy to discuss the initial details with you in our free consultation.

Our services relating to EN ISO 14971

  • Workshops and seminars to train your team: Tailored exactly to your needs, we discuss your individual questions together.
  • Moderation of risk analyses: Your team has the product-specific expertise, we take care of the timely implementation of risk analysis.
  • Development and optimization of the risk management process: Risk management is a central component of your quality management system. We take care that the process is efficiently integrated into your system.
  • Integration of the risk management results into the technical documentation: We ensure that the risk management is appropriately linked to the other parts of your technical documentation.
  • Verification of risk management measures: For your risk management measures you do not only have to prove that they have been implemented properly, but also that they are effective. We are happy to support you in planning and implementing your verification measures.

The risk management file

The risk management file as an element of the technical documentation documents all activities that are planned and executed in the context of risk management. For you as the manufacturer it is documented proof that you completed all required activities.

All standard?

Directive 93/42/EEC and regulation 2017/745, DIN EN 60601-1, DIN EN ISO 10993-1, DIN EN 62304, DIN EN 62366… Did you really consider everything?
Let's find out in an initial consultation together.

Dunja Schildge-Reichmann - Head of Regulatory Affairs & Quality Management

Dunja Schildge-Reichmann

Head of Regulatory Affairs & Quality Management

Our services for your risk management

  • Preparing the risk management file consisting of:
    • Risk management plan,
    • Preparation and moderation of risk analyses,
    • Risk assessment and development of risk-reducing measures,
    • Verification of measures, their effectiveness and traceability,
    • Risk management report.
  • Assessing existing risk management files against current standard requirements and implementing new requirements.
  • Identifying and analyzing non-conformities in risk management and developing possible improvements in the scope of the existing QM system.
  • Adapting the risk analysis throughout the entire product lifecycle.

Fit for today, fit for the future!

Our workshops give you the competence you need and help you master your current challenges. Let us find out together what you really need. Our expert workshops are always sustainable and individually tailored.

Get more information now