The NoBoCap project recently completed the first cohort of its ambitious MDR (Medical Device Regulation) master’s Level Module 1 “Implementing Regulatory Requirements for Medical Devices” led by SGS (NB 1639) and TU Dublin. The training aimed at improving capability across market operators to support the implementation of MDR in the medical device industry. This innovative course was designed to address the need to improve the competence of those responsible for the implementation of MDR in the rapidly evolving medical device sector, particularly considering new regulatory challenges. The first cohort was formed of 26 persons, from which 25 completed the module and 20 passed the exam.

The course was meticulously structured over ten learning weeks, providing a comprehensive overview of the MDR framework. It included specific themes like ISO 13485, technical documentation, risks, sterilisation and process validation, biocompatibility and QMS software validation, and clinical validation, that covered key aspects of medical device regulation, with an emphasis on practical application and understanding the auditor’s expectations. Participants engaged in detailed studies of technical documentation, risk management, and the nuances of quality management systems under the MDR.

The post-programme evaluation, conducted in October 2023, revealed insightful feedback from the participants. On average, the course met the initial expectations of the attendees, The programme’s structure results provided insights for improvement in content delivery and organization.

Key feedback highlights included:

• The course’s duration was generally well-received, with most participants finding the ten-week timescale appropriate.
• Some areas for improvement were identified, such as the need for more in-depth coverage of medical device software and electrical safety.
• The assessment component of the course was deemed adequate by most participants, aligning well with the course’s objectives and helping to cement the knowledge gained.
• A notable average rating of 3.75 for the recommendation of the course to peers suggests a strong endorsement from participants.
• The course successfully equipped most attendees with the skills and confidence to implement regulatory requirements in their organizations.

The success of the MDR Masters Level Module signifies a positive step toward addressing the skill gaps in the medical device industry. The course imparted essential regulatory knowledge and inspired many participants to consider careers as auditors or product assessors in notified bodies.

Looking ahead, NoBoCap project partners plan to continue developing and refining this module, integrating participant feedback to enhance the learning experience. The project also aims to introduce additional modules focusing on different aspects of medical device regulation, fostering a well-rounded understanding of the field.

In conclusion, the MDR Masters Level Module by NoBoCap partners (SGS and TU Dublin) has significantly contributed to the medical device sector. The positive outcomes and constructive feedback from the participants underscore the effectiveness of this initiative in meeting the industry’s evolving needs.

For details on further modules and how to register, keep an eye on the NoBoCap website.