Your Medical Device Manufacture

Once your product design phase is beyond concept engaging with Cogent Technology is where your device will first come to life, crafted in the safe hands of our experienced team. Our team will support you on a project pathway right through to ultimate market approval (FDA, CE, UL) for the destinations your devices will be deployed. You can engage with our team for the full portfolio of below services or just the key elements you require to bring your designs to fruition:

Project plan

Cogent can produce a project plan for your devices journey from Concept into Series Manufacture. Our planners are Prince 2 qualified, incorporating all the intricacies down to design and suppler approval for specialised parts and lead times, giving our teams an understanding of real time issues and the impact to deliverable time lines. Information is powerful and the project plan delivers our teams the information to react to achieve a positive outcome for your plan…….it’s a tried and tested route to success, see our case studies.

QMS Deployment

Many great innovations precede the Quality Systems you need in your business for your product to be approved.

To ease the transition to a certified company Cogent have a deployable Quality Management System which can be implemented and supported through to Notified Body certification. Our Quality Manager sits on the BSI Technical Committee for Medical Devices in the UK, which allows us to keep abreast of the latest requirements and industry direction.

Regulatory and Product Development Consultancy

If you need a technical file audit, or need guidance or support to meet regulatory requirements, you can tap into years of industry experience by using Cogent’s medical device consulting services.

Beta Design Consultancy

Cogent’s manufacturing engineering team brings Productionisation and validation for manufacture; casting our expertise over your bills of materials including hydraulics, pneumatics, mechatronics, precision placing, dispensing control, user interfaces, thermal control PCB Layout, metal work, piping, moving parts and plastics case designs. This review at an early stage can save valuable monies and time within the project plan.

During this stage Cogent are able to add detail to the cost model to give you a better understanding of what it will cost to manufacture your medical device.

We also generate technical files for regulatory submission.

Material planning

Securing Materials for all the levels of project manufacture, from trials to Market, is a complex operation not to be taken for granted. With defined budgets, component lead-times, obsolescence, last time purchases, premium agreed purchases, MOQ liabilities all impacting on the commercial unit price, and development costs all to be taken into account, Cogent will give you a point of contact to manage this though weekly project meetings allowing your team to be focus on other key elements and mile stones.

Manufacturing

All services unpinned by Manufacturing within an FDA inspected facility

Cogent offers the whole Manufacturing project pack service to meet your Medical Device needs

  • Fast Track, for the development of prototypes with rapid turnaround times
  • NPI – bringing control and expertise enhanced with PFMEA and DFM feedback, to ensure your product is ready for full-scale production.
  • Series Production, offering flexibility through scheduled orders and the beneficial option of our Kanban service.