How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

The Challenge

X-Bolt Trauma Orthopedics is a cutting-edge medical device company dedicated to transforming trauma treatment through advanced orthopedic implant systems.

Their core technology centres around innovative fixation solutions that deliver superior stability, particularly in patients with compromised bone quality. While their flagship Pro-X1 system is designed for the fixation of proximal femoral fractures, they are actively expanding into other areas of trauma—developing devices that address a broader range of skeletal injuries with the same commitment to biomechanical performance and clinical value.

Bernard Wallace, Quality Affairs Manager, explains “As a fast-paced medical device startup navigating the complexities of ISO 13485, EU MDR, and FDA QSR, we needed a training partner that could keep up with both our regulatory demands and our team’s schedule. What attracted X-Bolt to Comply Guru was their combination of accredited training, on-demand access, and clear, digestible content. The flexibility to complete modules at our own pace was a huge draw, especially when balancing multiple ongoing projects.”

The Solution

Since early 2024, Comply Guru has ensured X-Bolt’s staff has remained up-to-date on medical device quality standards & regulations, as well as equipped with the skills, to meet their QA/RA obligations & demands.

To help achieve this, the X-Bolt team successfully completed the following globally recognized credentials with Comply Guru:

• ISO 13485 Requirements for Practitioners & Auditors
• ISO 14971 Requirements for Practitioners & Auditors
• EU MDR 2017/745 Requirements for Practitioners & Auditors
• CAPA Practitioner
• Advanced Risk Practitioner
• ISO 13485 Lead Auditor

The above credentials are approved by CQI and IRCA and/or the Regulatory Affairs Professionals Society (RAPS). For more information on these courses, view our MedTech QARA Training Portfolio here.

“The training was exceptionally well-structured, engaging, and practical. It was evident that the content wasn’t just theoretical—it was designed by people who understand the real-world challenges of regulatory compliance. The mix of interactive elements and self-paced learning helped reinforce key concepts in a way that stuck.”

Bernard Wallace

Quality Affairs Manager

The Results

Through industry-leading eLearning & Blended Learning Methodologies, X-Bolt’s QA/RA team were able to flexibly upskill while balancing multiple ongoing projects. Bernard highlights the following benefits of working with Comply Guru:

• Availability of On-Demand & Flexible Learning vs other providers
• Stronger Internal Audits
• Clearer Regulatory Alignment
• More Confident QA/RA Team

“We’ve been able to improve the effectiveness of our QMS and respond more proactively to audit findings. I’d confidently recommend Comply Guru to any organization looking for serious, flexible, and high-quality training in the regulated space.”

Bernard Wallace

Quality Affairs Manager