Headsafe gets MDSAP certification to speed global expansion

By AI, Created 1:01 PM UTC, May 19, 2026, /AGP/ – Headsafe said May 19, 2026, that its manufacturing arm received an MDSAP Certificate of Registration from Intertek, a step that supports regulatory access in Australia and the U.S. and could open future pathways in Japan, Brazil and Canada. The company expects the move to help it pursue Australian commercial launch as early as Q3 2026.

Why it matters: - The certification gives Headsafe a clearer regulatory path in Australia, its home market, as the company looks to expand beyond the U.S. - The milestone may also support future access in Japan, Brazil and Canada, three markets that recognize MDSAP in their medical device frameworks. - Headsafe expects Australian commercial activity to begin by Q3 2026 if it secures a Conformity Assessment Certificate from the Therapeutic Goods Administration.

What happened: - Headsafe MFG Pty Ltd. received a Medical Device Single Audit Program Certificate of Registration from Intertek on May 19, 2026. - The certificate confirms conformance to ISO 13485:2016. - The registration supports regulatory requirements in Australia and the United States. - Headsafe said the move advances its international commercialization strategy.

The details: - MDSAP can streamline regulatory work for medical device companies seeking market access in multiple countries. - Headsafe plans to use the certification to support its application for a TGA Conformity Assessment Certificate. - Australia is a priority market because of its advanced healthcare infrastructure, public investment in medical innovation and established adoption pathways for new medical technologies. - The Australian MedTech market was valued at about US $8.5 billion in 2024/5. - Headsafe intends to evaluate Japan, Brazil and Canada over time based on strategic priorities, market readiness and commercial fit. - The company’s flagship product, Nurochek™, is an FDA-cleared portable EEG system that provides objective brain function data as an aid to diagnosing concussion after mild traumatic brain injury. - Nurochek™ uses visual evoked potentials to generate and analyze brain-response data. - The system delivers results in about two minutes. - Nurochek™ does not require a baseline test. - The product is aimed at emergency medicine, urgent care, sports medicine and other time-sensitive clinical settings. - Nurochek™ is intended for healthcare facilities and is designed for use in emergency departments, urgent care, neurology clinics and sports medicine settings. - The device is FDA-cleared as an aid in diagnosing mild traumatic brain injury and concussion when used with a standard neurological assessment. - The clearance applies to patients ages 12 to 44 within 120 hours of a potential head injury. - Exclusion criteria include seizure history, epilepsy, existing structural brain injuries and legal blindness.

Between the lines: - The certification is both a quality-system signal and a commercialization tool, which matters for a medtech company trying to move from regulatory progress to revenue. - Headsafe is positioning Nurochek™ as a practical clinical workflow product, not just a diagnostic device, by emphasizing speed, no baseline requirement and frontline care use. - CEO Craig Corrance said Australia is a logical next step because of its healthcare system, regulatory pathway and need for concussion assessment tools. - Chief Strategy and Commercial Officer Philip Gower said the certification reflects disciplined work across quality and regulatory systems and supports the company’s goal of becoming a global brain health company.

What’s next: - Headsafe will pursue its TGA application in Australia. - The company will assess entry opportunities in Japan, Brazil and Canada over time. - Headsafe plans to use the certification to support commercial planning and market development in the antipodean region. - The company is focusing on adoption across healthcare settings where concussion evaluation is hard to standardize. - Media inquiries can be sent to info@headsafe.com, and more information is available at the company’s website.