QAdvis is delighted to announce that Anna-Karin Alm has joined QAdvis as the new CEO, effective from February 1st 2025.

We are delighted to announce the appointment of Anna-Karin Alm as the new CEO of QAdvis AB, succeeding Robert Ginsberg, who has decided to step down from this position. Anna-Karin also assumes the QA/RA Business Area Head position in Aurevia, and is a member of the Aurevia Management team.

Anna-Karin is an experienced leader with over 20 years in leading roles within the Medical Technology sector. She is dedicated to defining and improving organizations and has worked in medical device companies throughout her career.

Anna-Karin brings a diverse set of leadership skills, having held positions such as CEO, Director of Medical Device Compliance, Director of Operational Excellence, Senior Consultant and Business Development Manager. Anna-Karin has also led multiple cross-functional and cross-cultural development teams and improvement projects. She emphasizes that product quality and corporate quality are essential for medtech companies, and she is committed to securing the success of our company by streamlining these services. Most recently, she has worked at Prevas AB (SDS MedteQ AB) and SHL Group AB.

 “I am delighted to introduce Anna-Karin as our new CEO. She brings a wealth of experience, fresh perspectives, and a strong commitment to the values that have shaped our company. I have full confidence that she will lead QAdvis into an exciting future together with Aurevia” says former QAdvis CEO Robert Ginsberg.

“I feel proud to be part of this experienced and skilled team of quality and regulatory experts within QAdvis and Aurevia. Our team has a broad set of skills, not only within our own business area, but also with colleagues within the CRO part of the organization. Together we will enable access for clients to the best experts within the broad medtech field.”, concludes Anna-Karin Alm.

Anna-Karins special interest in making the whole organization grow through strategic deployment work will be a great asset to QAdvis continued growth together with Aurevia.

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We at QAdvis want to wish you a joyful holiday season and say thanks for what we have achieved together throughout the year. As a part of the Labquality family we look forward to continuing our journey with all clients, colleagues and partners in 2025.

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Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over measuring and monitoring processes, equipment, and calibration—a requirement that is easy to underestimate or overlook.

EN ISO 13485:2016/A11:2021 contains a section (7.6) dedicated to the control of monitoring and measuring equipment, which includes both a determination of the monitoring and measurements to be taken and the equipment needed to provide evidence of conformity of products to applicable requirements. As part of the harmonization of the ISO 13485 standard, this section is identified as covering the legal requirements specified in both the EU 2017/745 MDR & 2017/746 IVDR (specifically as part of conformity assessments in Annex IX & XI).

The accuracy, precision, and stability of devices with diagnostic or measuring function are also identified in the GSPR of both the MDR (#15) and IVDR (#14), with reference to appropriate scientific and technical methods and identification of the limits of accuracy.

Additional guidance can be found in the international standard ISO 10012 which is applicable to any organization where measurement processes influence product quality and addresses both the technical and management aspects of measurement systems by:

  • ensuring that measurement processes and equipment support product conformity requirements, and
  • providing confidence in the accuracy and reliability of measurement results.

To be compliant, manufacturers typically need to consider a wide range of activities including:

  • unique identification of each piece of measuring equipment and its calibration status, including relevant labelling.
  • scheduling of calibration appropriate to the equipment type, usage frequency and risk of incorrect measurements
  • performing calibrations using standards traceable to national or international norms (or provide detailed rationales for the choice of other methods)
  • regular verification of equipment accuracy using control samples or secondary standards
  • safeguarding against adjustments invalidating measurement results and protection from damage and deterioration during handling, maintenance, and storage (including control of the relevant environment).
  • validation of software used for monitoring and measurement, with risk–based approach for revalidation, particularly after changes.
  • training personnel in equipment use, calibration and maintenance.
  • handling nonconformities related to out of specification equipment, including recalibration or replacement and impact assessment on previously productions based on potentially incorrect measurements.
  • maintenance of records in a format accessible to audits & inspections.

The content in the organization’s standard operating procedures therefore needs to clearly establish a standardized workflow for the control, calibration, and maintenance of measuring and monitoring equipment used in production, testing and inspection. 

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Human Factors Engineering (HFE) or Usability Engineering (UE) isn’t just about functionality and regulatory compliance, it’s about ensuring that devices are safe and easy to use for the end users by understanding human capabilities and limitations.

The evolution of usability guidelines and standards for medical devices highlights an increasing recognition of the crucial role human factors play in device safety. The International Organization for Standardization (ISO) began formally addressing usability in the early 2000s. The development of ISO 13485 (Quality Management Systems for Medical Devices) underscored the importance of incorporating user-centered design into quality management processes.

The publication of IEC 62366 in 2007 marked another significant milestone in usability engineering. This standard outlines the process for manufacturers to analyze, define, develop, and evaluate the usability of medical devices. It establishes detailed requirements for usability engineering to ensure that medical devices are designed to minimize use errors and enhance overall safety. It emphasizes the necessity of usability testing throughout the product development lifecycle to identify and mitigate potential use-related risks.

In 2016, the FDA issued a guideline on Applying Human Factors and Usability Engineering to Medical Devices, emphasizing the importance of usability in medical devices. The FDA’s guidance highlights the necessity for manufacturers to conduct comprehensive usability testing and demonstrate that devices are designed to minimize the potential for use-related errors. While there are many similarities between EU and US requirements, key differences exist.

For instance, the FDA stresses that testing should involve representative groups of users likely to operate the device in each of its intended contexts. The guidance also recommends that the number of participants shall be sufficient to identify usability issues effectively, suggesting a minimum of 15 participants. In contrast, the EU’s requirements, particularly those outlined in the ISO 62366 standard, do not specify a minimum number of participants but emphasize involving representative users throughout the usability testing process. Both regions recognize the necessity of evaluating devices in real-world scenarios, but the FDA provides a more defined framework on participant characteristics and study design.

Additionally, while the FDA emphasizes the importance of human factors and usability testing as part of the device approval process, the ISO 62366 standard, which is closely aligned with EU regulations, mandates a systematic approach to usability engineering throughout the product lifecycle. This approach includes assessing the device’s usability and integrating user feedback into design revisions to enhance safety and performance as part of post-market requirements.

The IEC 60601 series of standards, which focus on the safety and effectiveness of medical electrical equipment, have also incorporated usability considerations in later revisions. These standards now require manufacturers to assess usability as part of the risk management process (including identification of use related hazards), recognizing that use errors can result in significant risks.

The focus on usability engineering is well-justified. A 2018 study by Johns Hopkins estimates that over 250,000 deaths occur annually in the U.S. due to medical errors, many of which are related to human factors. While Europe may not have a unified study directly comparable to those in the U.S., several studies and reports highlight similar challenges across the European healthcare systems, thereby underscoring the importance of Usability Engineering.

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