Services
Message
Contact

Services

A single-source solution for design, development, and manufacturing of medical, diagnostic, and laboratory instruments.

With over four decades of industry experience, we know what will work, what won’t, and what requires fine-tuning. Our designers, engineers, technicians, and operators have the expertise and specialist know-how to give the product development process structure, efficiency, and speed.

Our Services

Concept Development

Whether we’re starting from scratch or building upon an existing design, our team will generate early design concepts and proof of principle prototypes to identify key risk areas, establish feasibility and ensure all requirements are met.

Design & Engineering

Utilizing advanced tools and state-of-the-art technology, our integrated team will refine your concept through detailed design, rigorous engineering, prototyping, and testing, to deliver complex, finished devices ready for transfer to manufacturing.

Contract Manufacturing

Fast, flexible, and reliable manufacturing solutions, from prototyping and pilot production to volume manufacture and after-market servicing, your device will be assembled, tested, and packed within an ISO certified and FDA registered environment.

Regulatory Consulting

Our regulatory affairs and quality assurance experts can help you navigate the complex regulatory landscape and achieve compliance for your device. We provide support throughout development, validation, certification, and manufacturing of your device

Our comprehensive, flexible solutions help to progress your medical device quickly, reliably, and cost-effectively through every phase of its development lifecycle. From concept development to contract manufacturing and after-market servicing and support, all delivered to the highest standards by our experienced team.

We operate an ISO 13485 and ISO 9001 certified, FDA-compliant design and manufacturing process, focused on minimizing risk, meeting regulatory requirements, and providing our customers with a full-service solution.

 

 

BSI assurance mark 9001 13485 black

Discover how we can support your next medical innovation

Whether you’re looking to develop an idea or concept into a commercially viable product, or you need help progressing one specific stage of your project, we can help.