At ANJEN Solutions, we provide expert medical device consulting services tailored for start-ups and early-stage companies across New Zealand. Whether you’re developing your first device or navigating complex regulatory pathways, our team brings deep technical knowledge and regulatory expertise to help you succeed.

With hands-on experience in engineering, operations, and quality systems, we guide you through the product lifecycle, from concept to commercialisation. Our services are underpinned by practical knowledge of ISO 13485, FDA 21 CFR 820, CE marking, and other international standards.

As a locally based consultancy with global reach, we offer responsive, strategic support to help you minimise risks and accelerate time to market.