apartis quality standard EN

apartis quality standards

Zero-defect tolerance

As with medicines and medical devices, all software employed in the medical or pharmaceutical area is subject to the highest safety requirements.

apartis – FDA and CE IVD quality standards

As with medicines and medical devices, all software employed in the medical or pharmaceutical area is subject to the highest safety requirements. apartis takes every step throughout the entire software development process to prevent errors and minimize risks. Needs and feasibility studies before programming begins are conducted as a matter of course. Continuous checks during every phase of the development guarantee maximum quality.

Our products consistently receive top audit and certification ratings and also meet the strict requirements of the American Food & Drug Administration (FDA) in respect of quality and documentation.

Before new software is released it first undergoes stringent tests in our 400m² testing laboratory. This is equipped with a completely independent network environment to exclude any external interference. We verify and validate the results, analyze the risks at all system levels and control the traceability of the processes involved. Tests are performed on actual devices or virtual machines depending upon requirements.

In addition to function tests we also conduct stress and load tests at maximum configuration. These are largely performed automatically with leading off-the-shelf programs and apartis tools. We also employ hybrid technologies, e.g. in the preparation phase, to save time and ensure transparency.

We've recently completely updated and improved our quality system in order to support the latest standards for medical devices. Our quality system is strictly aligned with the following regulatory requirements

  • ISO 13485 – Quality Management System for Medical Devices
  • ISO 62304 – Software Development Lifecycle Process for Medical Devices
  • ISO 62366 – Application of Usability Engineering for Medical Devices
  • ISO 14971 - Application of Risk Management to Medical Devices
  • 21CFR820 – Quality System Regulation
  • 21CFR11 – Electronic Records and Electronic Signatures 

Our goal for this year is to certify our quality system for ISO 13485.