Elevate MedTech notes that IEC 62366-3 is a committee draft under review for usability engineering guidance for AI and ML-based devices.

Elevate MedTech brings together deep regulatory, clinical, and commercial expertise to support innovators across the full medical device and digital health pathway. From concept to market access, we guide manufacturers through design, compliance, and international approvals with precision and practical insight. With a strong presence in New Zealand and Australia and connections across the UK, EU, and US, Elevate MedTech provides end-to-end support for regulatory affairs, quality management, and clinical validation. Our multidisciplinary team delivers: ⏺ Regulatory consulting and training covering SaMD, IVDs, QMS, cybersecurity, human factors, and technical documentation. ⏺ QA/RA and clinical consulting, including fractional QA/RA, audit preparation, and independent reviews. ⏺ Clinical insight from practising medical specialists. ⏺ Biocompatibility and toxicology expertise. ⏺ Trusted sponsorship for medical devices in New Zealand and Australia. ⏺ Digital tools such as Regulatory Radar and Post-Market Radar to streamline compliance and surveillance. ⏺ Commercialisation strategy and go-to-market support for MedTech, Digital Health, and BioPharma companies. Through our Medical Device University, tailored seminars, and workshops, we empower clients with the knowledge and confidence to meet global regulatory expectations and accelerate market success. Rely on Elevate MedTech as your trusted partner for regulatory affairs, clinical consulting, and international market access. Contact us at info@elevate-med.tech or visit elevate-med.tech

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