Scaling pediatric innovation: AIBODY’s journey to BSI QMS certification
● Context
AIBODY, an innovator in cardiovascular software, developed Nova Heart to optimize pediatric outpatient assessments for patients with congenital heart disease.
The product is working towards Software-as-a-Medical-Device, that aggregates echocardiography data to automate Z-scores, growth chart percentiles, and 3D heart modeling.
Navigating the transition into the stringent EU MDR (2017/745) environment required a partner who could manage the regulatory burden without stifling the development pace. AIBODY engaged Star to lead their regulatory strategy, Quality Management System implementation, and clinical software lifecycle governance.
● Impact
Working with Star, AIBODY successfully:
- Achieved QMS certification: Successfully implemented a QMS compliant with ISO 13485:2016 passing both initial and 1st surveillance certification audit by BSI and working towards EU MDR.
- Optimized regulatory strategy scope: Reduced compliance complexity by strategically dividing the product into medical and educational components.
- Institutionalized compliance: Delivered comprehensive training and onboarding, embedding regulatory awareness into the engineering and clinical teams.
- Accelerated market readiness: Built a robust Technical File architecture, positioning AIBODY to trigger the CE mark assessment immediately upon completion of the development phase.
● Journey
Our strategy focused on transforming regulatory requirements from a "blocker" into a structured roadmap for the Nova Heart SDLC.
To optimize the regulatory burden, we divided Nova Heart into two distinct functional groups:
- Medical device component: Features for outpatient clinical assessment using real patient data, including pathological grading based on medical literature.
- Educational component: A modularized segment intended for medical students and caregivers using simulated data, allowing for broader use outside strictly controlled clinical environments.
● What's next?
As AIBODY finalizes the Nova Heart product development, the regulatory foundation is already "audit-ready." Star continues to support the team as they prepare for the final technical assessment to obtain the CE mark.
With a certified QMS and a clear regulatory strategy, AIBODY is ready to deliver high - impact cardiac care to the pediatric population.
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