We are delighted to share a major milestone in our innovation journey: SurePulse is now officially MDSAP certified (Medical Device Single Audit Program). This internationally recognised certification reflects the strength and maturity of our quality management system and underscores our commitment to delivering safe, effective, and compliant neonatal monitoring technologies.

What is MDSAP and Why Does It Matter?

The Medical Device Single Audit Program (MDSAP) allows a single, comprehensive quality audit to satisfy the regulatory requirements of multiple participating countries. The audit process is known for its depth and rigour—covering everything from product development and risk management to post-market surveillance and customer feedback handling.

With MDSAP certification, SurePulse is now recognised as meeting the regulatory standards for:

• 🇺🇸 United States – U.S. Food and Drug Administration (FDA)

• 🇧🇷 Brazil – Brazilian Health Regulatory Agency (ANVISA)

…and we are actively working to expand into further MDSAP-participating regions in the near future.

Why This Milestone Matters

Achieving MDSAP certification is more than just a regulatory checkbox—it’s a clear signal to our partners, healthcare providers, and parents that SurePulse puts quality, safety, and clinical excellence first. It enables us to accelerate our market access in key regions and reinforces our commitment to global standards of care.

This milestone also brings us one step closer to realising our mission: to place babies and their families at the centre of neonatal care by delivering innovative, reliable monitoring technologies that support better outcomes—from the moment of birth through to discharge and home.

A Team Effort Worth Celebrating

We want to take this opportunity to thank our incredible team for their relentless dedication, expertise, and passion. Achieving MDSAP certification is a demanding process, and team member across SurePulse played a role in making this happen.

As we continue to grow and expand internationally, this achievement strengthens the foundation upon which we build future innovation—ensuring we meet the highest expectations of clinicians, regulators, and most importantly, the families we serve.