Risk Management for Medical Devices and In Vitro Diagnostics

There is a particularly high level of protection, which is why the remaining residual risk must be weighed against the benefits of the product. German, European and American legislation for medical devices all require risk management for medical devices and in-vitro diagnostics.

The procedure according to ISO 14971

ISO 14971 pertains to the field of medical technology and is titled “Medical devices—Application of risk management to medical devices.” It describes risk management and is applicable internationally.

The internationally recognized ISO 14971 standard specifies the following procedure:

  • Hazards posed by the medical device or its accessories must be assessed, evaluated, and controlled.

  • Effectiveness must be monitored through controls.

  • The requirements of the standard apply during all phases of the product life cycle of a medical device.

If these risks are not identified and eliminated in a timely manner, this can have far-reaching consequences. Under the Medical Devices Act and the Medical Device Regulation (MDR), risk management is a mandatory requirement.

Our risk management service portfolio is designed to support manufacturers in precisely meeting international standards and regulations. From extensive planning and risk assessment to the implementation of effective risk minimization strategies, we support our customers throughout the entire product life cycle.

From the Field: Projects That Make a Difference

How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.

TNI medical, Cybersecurity GAP-Analyse, Success Story von BAYOOMED

Collaboration with TNI medical
Cybersecurity Gap Analysis for Audit Preparation
Here’s how we did it: Collaboration with TNI medical

Cimon Medical

NeoDoppler
Hardware and software engineering through to MDR certification
Here’s how we did it: NeoDoppler

Behind each of these stories was an initial conversation. Write your success story with us and tell us what you’re currently working on.

Risk management for your medical device – maximum quality and safety

We offer customized solutions that not only meet regulatory requirements but also contribute to the continuous improvement of products. Our experienced risk managers understand the complexity of ISO 14971 and offer you comprehensive support to optimize risk management for medical devices. This is the only way we can guarantee the highest quality and safety for patients.