CASE STUDY
Securing FDA and CE Marking approval for HoloCare AS’s Class IIb medical device
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CASE STUDY
Securing FDA and CE Marking approval for HoloCare AS’s Class IIb medical device
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Delivered compliant technical file documentation
to achieve market approvals
Healthcare startup, specialising in augmented reality application for surgical planning.
Outcome
Integrated seamlessly: With HoloCare AS’s engineering team, handling the entire regulatory documentation process, so their engineers could focus on development.
Comprehensive documentation: All required technical documentation, including risk management, and software validation
Secured approvals: Allowing HoloCare AS to commercialize their Class IIb device
Challenge
- Remote working team spread across Europe
- Managing timelines to fulfil investors
- Introducing processes across multi-displincary team
About this health company
This health solutions startup, specialising in enabling surgical planning through the use of augmented reality imaging, partner with us to streamline their compliance journey.
Location: Norway
Company size: Start-up
Industry: Medical
Real game-changer for us. It makes the whole regulatory process so much more manageable and efficient.
CEO, Holocare AS
Approach
Integration with HoloCare AS’s Team
Rather than disrupting internal workflows, we embedded compliance into their development cycle, ensuring all regulatory requirements were met without pulling engineers away from product development.
Technical Documentation & Risk Management
We handled all documentation, including ISO 14971 risk management, IEC 62304 software validation, and usability testing (IEC 62366-1), ensuring a fully compliant submission.
Safety Testing and Validation
We conducted verification and validation (V&V) testing both for software and electrical safety utilising our network of test houses where required.
Submission Process
We prepared and compiled technical documentation, liaised with Notified Bodies and the FDA, and ensured HoloCare AS’s submission process was streamlined, efficient, and successful.
Bringing medical imaging into 3D
Augmented Reality (AR) is revolutionizing medical imaging and surgical planning, providing clinicians with interactive, 3D visualizations that enhance precision, decision-making, and patient outcomes. By overlaying real-time holographic images onto the surgical field, AR enables surgeons to better understand complex anatomical structures, improve preoperative planning, and reduce surgical risks.
As AR adoption grows in healthcare, ensuring these technologies meet regulatory and clinical requirements is critical for widespread implementation. By securing FDA and CE Marking approval, HoloCare AS has positioned itself at the forefront of next-generation medical imaging, demonstrating how compliant, clinically validated AR solutions can shape the future of precision medicine, training, and patient care.
We did what looked like mission impossible in February this year. We set this goal and just pushed forward brick by brick laying the foundation of the roadway ahead with this milestone.
