Prolaio's ISO 13485 Certification—and Why It Matters in a Rapidly Evolving Regulatory Landscape
The global medical device industry is entering a pivotal chapter. As regulatory bodies move toward greater harmonization and higher standards, companies are being called to not only meet today’s expectations—but to anticipate tomorrow’s.
At Prolaio, we’ve always believed that quality is a mindset. That belief has guided how we build, how we operate, and how we prepare for what’s next. And this month, we’re proud to share a milestone that reflects that commitment.
Prolaio is now certified to ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).
This achievement validates the strength of our quality management system across the full product lifecycle—from design and development through manufacturing—and positions us to scale in alignment with the highest standards in the industry.
“This certification validates our resolute commitment to quality across our entire organization in the delivery of safe and effective medical devices to our patients and to the life-science industry at large.” — Tassos Gianakakos, CEO, Prolaio
Why ISO 13485:2016 Matters More Than Ever
While ISO 13485:2016 is the international standard for medical device quality, it's now set to take center stage in the U.S. as well. The FDA has announced plans to adopt ISO 13485 by reference by 2026, effectively harmonizing FDA’s own Quality System Regulation (21 CFR Part 820).
Built for the Future: Inside Prolaio’s QMS
Our ISO 13485:2016 and MDSAP certifications reflect a quality-first foundation that has been in place since day one. Our QMS integrates both U.S. and international requirements, built to support scale, innovation, and patient safety.
Key pillars include:
- Risk-based design controls that prioritize safety and performance at every stage
- Robust CAPA systems that proactively identify and resolve issues
- Document and record control designed for traceability and audit readiness
- Ongoing training and competency programs that make quality a company-wide responsibility and mindset
This infrastructure isn’t static. Our certification marks the beginning of a continual quality assurance program, including regular audits, to ensure ongoing compliance and drive improvement across every team.
The Business Value of Certification
Compliance is the baseline. It’s a comprehensive framework that strengthens how an organization operates, collaborates, and scales. What matters more is what certification enables.
For Prolaio, ISO 13485:2016 and MDSAP certification mean:
- Stronger collaboration with healthcare partners and regulators
- Deeper patient trust in the tools they use to manage their heart health
- A culture of accountability, shared knowledge, and continuous innovation
Looking Ahead
Regulatory landscapes will continue to evolve and Prolaio is well positioned to keep pace as they do. Our foundation is strong, and our commitment is clear: to deliver data-driven heart health solutions that strive to meet the highest standards.
By aligning proactively with the direction of global regulation, we’re not just ready for the future. We’re helping shape it.
Disclosure
*This information is provided for general informational purposes and does not constitute legal or regulatory advice.*