Harbyne Consulting specialises in helping medical device companies design and implement risk based, fit-for-purpose quality and regulatory frameworks that meet ISO 13485 and global regulatory expectations without unnecessary complexity. We work with organisations to translate regulatory requirements into efficient, workable systems that support product development, manufacturing, scale-up, and ongoing market compliance.

Our approach is grounded in real operational experience. We don’t deliver theory - we deliver compliance that works, enabling businesses to operate efficiently, manage risk effectively, and grow with confidence in regulated markets.

If you’re looking to align compliance with performance, Harbyne can help.