Medical Device Manufacturing
Cirtec has all the systems in place to manage medical device manufacturing from start to finish. From supply chain management to packaging and sterilization management, our robust quality system ensures that the Device History Record compiled with every lot is complete and fully reviewed. Cirtec is experienced in meeting the demanding quality requirements for all aspects of medical device assembly and manufacturing. We offer flexible medical device manufacturing solutions that adjust to meet volume and lead time demands.
Cirtec Medical System’s considerable medical device contract assembly and manufacturing experience includes:
- Complex minimally invasive surgical devices
- Single use disposables
- Active and passive implantable devices
- Surgical equipment
- Diagnostic devices
- Interventional devices
- Laser welding
- Hermetic sealing
- Ultrasonic bonding
- Gross, fine and cumulative leak testing
- Full service in house metallurgical preparation and analysis of sub-surface weld characteristics
- Manufacturing staff certification maintained to solder standard IPC-610 with in house training/ re-certification capability and full ESD program for safe handling of electronics
- Full suite of dimensional inspection tools and equipment required for micro components
We maintain ISO 14644-1 Class 7 certified clean rooms at our East Longmeadow, Los Gatos and Valencia locations. Cirtec’s systems are ISO 13485 certified to fully support our client’s total production requirements. Our skilled staff of manufacturing technicians and assembly personnel are experts at a variety of fabrication, assembly, testing and packaging operations with lot-controlled and traceable materials and processes.
Cirtec works closely with our customers to identify the level of refinement needed for each prototype build with a flexible quality system. To facilitate rapid turnaround prototyping and keep costs contained, the early stages of product development can be performed outside Cirtec’s design release control system. Cirtec is equipped with machine shops in all locations for fabrication of components, fixtures, and tooling. Process development expertise allows the Cirtec team to quickly identify the best manufacturing processes to use in prototype fabrication. Cirtec also stocks a variety of typical off-the-shelf medical device materials and components for prototyping to alleviate the impact of component lead times. Beginning in the prototyping phase, Cirtec leverages our extensive medical device manufacturing experience to plan a process that will easily scale as volume needs change through the product life cycle.
Design for Manufacturability
At Cirtec, Design For Manufacturability (DFM) is a key component of medical device design that begins early in the development cycle. It is a bi-directional collaborative effort between manufacturing and design. Currently, our DFM methodology has been applied to products that we manufacture in our facility in volumes as low as 20 units per year to market production levels of >1,000 units per month. Designs developed with Cirtec’s DFM input result in a greater yield and shorter processing time during prototype and pilot production. Our DFM approach also yields designs that require less time and money to ramp up to higher volume manufacturing quantities.
Process Development & Qualifications
Process engineering at Cirtec is the selection and optimization of manufacturing processes that transform a collection of components and other inputs into a functional, marketable device. Cirtec excels at testing and monitoring processes to provide confidence that the end result is a robust and reliable medical product through process qualifications and real time statistical process monitoring. Cirtec matches a specific manufacturing process and overall production flow to anticipated volumes for each individual product line. Cirtec utilizes a variety of tools to improve processes, reduce cost, and provide value to customers as products transition into higher volume manufacturing. For example:
- Value stream mapping
- Continuous flow manufacturing
- Lean 6σ principles
- Supply chain management, including JIT inventory management and Kanban style pull
- Real time statistical process control