Navigate regulatory complexity with confidence
Independent regulatory affairs support for medtech and software-based device companies. Alanta Advisory helps start-ups, scale-ups and established manufacturers bring active medical devices, SaMD and AI/ML-enabled devices to market across Australia, Europe, the UK, New Zealand, the USA and Canada, from concept and design through post-market maintenance.
Independent Regulatory Expertise for Medtech
Alanta Advisory is led by Yervant Chijian, Director and Principal Consultant, who brings more than 20 years of medtech experience across product development, manufacturing, quality assurance and regulatory affairs. His practical guidance helps start-ups, scale-ups and established manufacturers turn complex requirements into clear, informed decisions.
From concept and design through pre-market submissions, launch and post-market maintenance, Yervant works collaboratively across Australia, Europe, the UK, New Zealand, the USA and Canada. Alanta Advisory supports active medical devices, Software as a Medical Device and AI/ML-enabled products, including regulatory strategy, quality systems, risk management, usability engineering and cybersecurity.
Regulatory clarity for every product stage
Alanta Advisory helps medtech, SaMD and AI/ML device companies turn complex regulatory requirements into clear, practical pathways to market. We support start-ups, scale-ups and established manufacturers across major global markets, such as Australia, Europe, the UK, and the USA.
Regulatory strategy and market access
Define the right regulatory pathway, evidence plan and submission strategy for your device. We prepare and support pre-market submissions across major global markets.
SaMD, AI/ML and product assurance
Navigate the requirements for active medical devices, Software as a Medical Device and AI/ML-enabled products. We align software development, usability engineering, risk management and cybersecurity with regulatory expectations.
Quality systems and post-market support
Develop or strengthen ISO 13485 and MDSAP quality management systems, address gaps and prepare for audits. We also support post-market maintenance, monitoring and compliance throughout the product lifecycle.
Let’s clarify your path to market
Whether you are an early-stage start-up, scaling medtech manufacturer or established developer, Alanta Advisory can help you navigate regulatory and quality requirements with confidence.
Contact us to discuss your needs.