The implementation of the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) have enhanced the requirements for the safety, quality, and performance of medical devices and in vitro diagnostics within the European Union. In the US the Quality System Regulation (QSR) part 820, recently updated to Quality Management System Regulation (QSMR), serves the same purpose.

These regulations aim to improve patient safety, ensure the reliability of medical devices, and strengthen regulatory oversight throughout the lifecycle of these products, from design and manufacturing to post-market surveillance. These regulations set out the requirements for a quality management system specific to the medical devices industry, e.g. ISO 13485. The manufacturer is therefore expected to demonstrate that their quality management processes are compliant and efficient in order to fully support the organization. This includes any software used in the QMS or manufacturing.

If you need support or training in computer system validation of SW used in manufacturing or within your quality management system, contact us for more information. We have proven experience in planning, execution, evaluation, and documentation in the performance of computer system validation. Our reference material is GAMP V or AAMI TIR 36, ISO/TR 80002-2 depending on your needs.

Example of other services we can provide:

  • Planning and designing the quality management system to support the organization’s processes and meet applicable regulations and standards, such as ISO 13485, MDR, IVDR, 21CFR820, etc.
  • Inclusion of other relevant standards such as ISO 14971, IEC 62304,
    ISO 62366-1, etc.
  • GAP analysis and roll-out plans for QMS changes.
  • Conducting audits.
  • Interim QA & RA manage
  • Acting as PRRC (Person Responsible for Regulatory Compliance).
  • Training sessions & materials (customized or in open class).

Contact us for further information

Our team can assist your organization in attaining compliance while boosting productivity within your organization. Contact us here if you have any questions or want to learn more about how we can support you.