Life Sciences

Woman receiving ultrasound

Life Sciences and Medical Devices

If you’re reading this because you have a PMA stage seal performance problem please contact us now to troubleshoot and find the best solution. Quickly. We can ship prototype compression molded seals in two weeks, LSR molded parts in 4-6 weeks, and cut elastomer shapes, plastics in hours or days. FDA and USP Cl VI stock seals ship same day. 
 
Whether your product is a predicate improvement or a novel Class II or Class III device we can help you find the best seal or media manifold/separator design.  If you are in prototype phase we can quickly help iterate when your seal element layout needs to change. We have strong relationships with fast turn LSR molding houses and access to premium USP Cl VI elastomer formulations.  When you’re ready to ramp our molders can scale quickly too, giving you plenty of time to validate parts from higher cavity count tooling. 
 
Quality comes first with Darcoid. Nothing moves without Quality’s approval.  Our team is driven to assure zero defects with control plans aligned to your quality process manual  - We secured ISO 9001 registration in 2002 and we continue to innovate, most recently securing  IATF 16949 registration in 2021.  We recognize specific QA and regulatory requirements for medical device industry applications including ISO 13485   
 
If you’re visiting this page because you are dealing with recurring quality escapes please contact us and book time with our QA experts..  Our QA team has developed a wealth of seal quality expertise over the years. When molded features on elastomer components are the same size as standard flash allowances you need a good understanding of process controls to assure critical CpK is maintained.  We know where and how escapes can happen at every step of the manufacturing process and what controls need to be in place and verified.
 
In new product design processes the integration of the sealing element(s) are frequently overlooked or considered an afterthought. Our technical team at Darcoid is driven to help you develop the best possible seal for your unique application.  Best success comes with close collaboration, so engage with a Darcoid applications engineer as early in your project as possible to assure your project timeline and budget stay on track.  
Surgeons undergoing an operation
 
A critical part of your program’s success is making sure the seal that gets assembled in your product 4 or 5 years from now performs the same as the seal you qualify for production release.  Small omissions or assumptions in your control specs can create major headaches in the future..  Darcoid Applications Engineers will teach you how to control  Seal Performance Creep so you can rest easy and focus on developing your next revolutionary medical device.   
 
Our fulfilment and supply chain teams’ mantra is “wherever and whenever you need it, your shipment will be there”. With inventory forward positioned in the USA, Europe and Asia we keep your lines running wherever in the world your product is assembled. Being easy to do business with is critical and everyone in our customer experience team is motivated and empowered to align with your business model to make that happen. 
 
Darcoid has been in business for over 60 years and over that time we have come to recognize one simple truth: The performance of your product is directly related to the quality and reliability of the seal. With those words in mind we continue to innovate and collaborate with customers whose products change the world for the better. To deliver meaningful and measurable value to your entire organization we have built and deployed the powerful Next Level™ strategy- by deliberately integrating with your teams in quality, seal technology, fulfillment services and growth strategy. True Partnership.
 
We’re looking forward to earning your trust and becoming your go-to seal solutions provider.