Market success with compliant and usable medical devices

A survey of reported incidents from BfArM has shown that at 42,1 percent of the incidents are based on usability issues of medical devices. 70% of FDA recalls of software products are due to usability problems.

International studies have shown that a lot of incidents with medical devices are caused by incorrect use of the device. Usability gets more and more in the interest of both, public and legislative authorities.

Since the MDD 93/42/EEA has been amended by the usability aspect in March 2010, all manufacturer of medical devices are now obliged to evaluate the usability within the development process and to design their products with a focus on the needs of the intended users.

MedSysCon provides support in implementing the requirements on usability and supports you in developing plans and specifications for the validation of your medical devices.

IEC 62366 – Requirements regarding the usability of medical devices

Usability engineering start in the early stages of the product development cycle rather than on the finished device.

Make use of our expertise right from the beginning to ensure the correct implementation of all IEC 62366 requirements.

Interaction of Usability, Risk Management and Clinical Evaluation

Usability is closely linked with risk management and clinical evaluation. MedSysCon supports you to comply with necessary chronological sequences and dependencies of the process flow.

MedSysCon: IEC 62366

IEC 62366

Usability according to the accepted standard

MedSysCon: Schnittstellen


Interaction of Usability, Risk Management and Clinical Evaluation

Your Benefits

  • We support you in compiling FDA and IEC 62366 compliant usability files.
  • We will support you in integrating the human factors / usability engineering process into your product development lifecycle and provide necessary training.
Do you have questions on the subject Usability?

We will be happy to provide you with comprehensive advice.

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