We provide a cost-effective outsourcing solution for the development of medical diagnostics within a compliant and seamless process to help our clients achieve market success efficiently, confidently, and with reduced risk. Our typical process delivers products within 3 – 4 years and results in cost-savings of around 90%
Covering every aspect of product lifecycle development, we begin with the design and technology development, full verification, and product validation. We also take the product through our prototyping, manufacturing validation, and scale-up processes, and finally clinical performance evaluations.
Finally, we deliver registration of the product and can assist with the launch to your chosen markets, the sale, marketing, and launch.
Successful diagnostic product development and launch requires a wide range of skills. Supporting the product positioning and branding of new products, our expert team is composed of:
- Experienced IVD Research and Development Managers
- Manufacturing and Operations professionals
- Senior Development Scientists
- Manufacturing Engineers
- Clinical Trials Managers
- Instrument Developers (Firmware, Software, and Hardware)
- Usability Engineers
- Mechanical Designers
- Labeling and Packaging Designers
- Regulatory Experts
- Sales and Marketing Managers
- QA Managers
Our accredited facilities
Our facilities are accredited to EN ISO13485:2016 for the design, development, manufacturing, and distribution for Medical and IVD companies.
Located at Magazine House in Bromborough, our accredited facilities are within easy reach of the region’s major specialist and university hospitals.
We have a seamlessly integrated approach to developing and manufacturing diagnostic products within our Bio-hazardous GLP product development and validation laboratories, Instrumentation Engineering Laboratory, and advanced GMP Manufacturing and Logistics Facility.