Newsletter No 46 June 2024

Subject: Ensuring Quality and Compliance – Process validation in the context of MDR

In the context of Regulation (EU) 2017/745 (MDR) on medical devices, process validation plays a crucial role in ensuring product safety, efficacy, and compliance. As part of our commitment to maintaining the highest standards in medical devices, in this month’s newsletter we have a look to process validation.

What is Process Validation?

Process validation is the systematic approach to confirming that a manufacturing process consistently produces medical devices or sterile procedure packs that meet predetermined specifications and quality standards. It involves assessing and documenting each step of the production process to minimize risks and ensure product reliability.

Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. The focus is the product and its properties. Verification involves ensuring each element of a device meets the appropriate specifications and standards.

Key Considerations:

  • Risk-Based Approach: MDR emphasizes a risk-based approach to process validation. Device manufacturers must identify critical process parameters, potential failure modes, and associated risks.

In the risk management we as device manufacturers assess whether the output can be verified through monitoring and measuring, and if this verification is sufficient and ensures 100% that the product complies with the specifications and intended use. If it is not sufficient, a validation is required.

  • All sites considered: The device manufacturer is responsible for the validations of the processes conducted in own facilities as well as in subcontractors and shall ensure that the subcontractors meet the same conditions as the devices manufactured in house.


  • Validation Protocols: The device manufacturer team develops comprehensive validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). These protocols ensure that equipment, processes, and systems meet predefined criteria.


  • Data Integrity: Accurate and reliable data are essential. Device manufacturers must maintain robust documentation, traceability, and data integrity practices to support the validation files.


  • Lifecycle Approach: Process validation is not a one-time event. It’s an ongoing process throughout the product lifecycle. Device manufacturers continuously monitor and evaluate the manufacturing processes, adapting as needed to maintain quality and compliance.

Which is the role of the distributors?

As valued distributors, your collaboration is vital. By understanding the importance of process validation, you can confidently communicate its benefits to healthcare professionals and end-users. Together, we contribute to safer, more effective medical devices.


This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at

The next MDR newsletter will be issued in July.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group