SYNEO offers contract services to meet your medical device manufacturing needs. SYNEO utilizes SYNEO machines and tooling to perform manufacturing functions on a contract basis. Please refer to the Equipment Solutions section for the range of machines that are available for contract services. SYNEO is capable of performing a single function or multiple functions on the tubing including cut-to-length services, hole-making, slitting, flaring, tipping and grinding, as well as laser-based solutions such as micro-machining and marking. Drilling, punching and skiving functions are accomplished using SYNEO cutting tools which can be viewed in Catheter Hole Making. Whether you are seeking a one-time production run or long-term support as your production ramps, SYNEO will provide the right solution for your contract manufacturing needs.
SYNEO’s mechanical and laser technologies are capable of processing a wide range of medical grade materials including wire-reinforced tubing. SYNEO has over 25 years of experience with a wide variety of materials, dimensions and lumen configurations. As numerous variations of materials exist, we recommend that you contact SYNEO to discuss your application. SYNEO will ask that you provide production quality samples and final part drawings and specifications, if available, to complete the evaluation process.
CONTRACT SERVICE PROCESS
Evaluation for Project Capabilities
The accuracy of the evaluation is greatly enhanced by receiving production quality raw material and detailed engineering drawings with desired specifications, tolerances and other product criteria. SYNEO will draw from extensive prior experience with a wide range of materials and its practical knowledge of the SYNEO machine and tooling capabilities to determine whether SYNEO can perform the desired contract services in a consistent and high-quality manner.
Contract Service Quote
SYNEO will provide a quote for the services desired and provide samples of the product used in the evaluation, if provided, to indicate the quality of the outcome that is achievable. In the absence of the material and final drawing, a budgetary or estimated quote will be generated which may need to be refined upon receipt of the raw material and final product drawing and specifications.
Contract Service Purchase Order
Once the evaluation and quote process has been completed and all critical specifications, tolerances and inspection criteria have been finalized, a purchase order is created by the customer and sent to SYNEO. SYNEO will determine the lead time for the project based on the quantities desired, whether any application-specific tooling is required and other current projects currently scheduled in the Contract Service Department.
Contract Service Standard Processing Time
Estimated lead times are determined after factoring in the specifications of each project and are listed on each quote. The standard lead time is 2 to 3 weeks from the receipt of both the purchase order and raw material at our facility. The lead time may be longer in the event specialized tooling is required or the quantities ordered are larger than originally expected. Standard lead times may also be affected by specific inspection or sorting procedures requested by the customer.
SYNEO utilizes machines and tooling that are proprietary to the Company to perform contract services. The SYNEO staff has in-depth knowledge of the capabilities of the equipment and tools that are deployed for each contract which assures the highest success rate and quality. The equipment and tooling is more readily adaptable to each specific application because of knowledge and experience of the SYNEO operators and supporting technical staff. Each of the machines listed under the Equipment Solutions tab may be used to provide contract services. Application-specific tooling can be developed by SYNEO to achieve the optimum results.
CLEAN ROOM ENVIRONMENT
An ISO 7 Class 10,000 Certified Clean Room is available for contract service processing. Specific gowning, booties, gloves, masks and footwear are available to meet the specific needs of the project.
SYNEO follows a rigorous Quality Management System that includes incoming, in-process and final inspections, data collection and retention and operating procedures covering the receipt of materials through packaging and shipping that assure the highest quality, repeatability and consistency of your products.
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