End-to-End Medical Device Manufacturing:
DFM to Regulatory Support
- Design for Manufacturability (DFM) & Assembly (DFMA)
- Prototyping & Process Development and Validation
- Materials sourcing and Supply chain Management
- Advanced Manufacturing & Assembly (e.g. printing, converting, mechanics & electronics assembly, testing, packaging, chemistry)
- Regulatory support for the product and process documentation, depending on the need
- Support for your navigation through biocompatibility and ISO 13485 requirements
- Mostly for Class I and Class IIa & IIb products
Rapid Prototyping to Scalable Manufacturing
Screentec, exploiting over 35 years of experience, offers comprehensive feasibility studies for printed electronics manufacturing. Whether for new product types or optimizing existing versions, we can help improve your product for cost-efficiency, technological advancement, or enhanced sustainability.
As your trusted manufacturing partner, Screentec offers rapid prototype development and flexible manufacturing for mass production. We tailor our comprehensive medical productization services to every phase, ensuring full compliance with ISO 13485:2016 and FDA QMSR 21 CFR Part 820. Our expertise is ideal for customers in niche sectors developing flagship products that require high integration, superb signal performance, or wearability – all manufactured efficiently from one location.
Screentec excels at overcoming complex manufacturing challenges, pioneering novel material applications and innovative process combinations, including advanced thermal management and chemistry. This expertise leads to significantly improved yields and reduced scrap costs through intelligent manufacturing process redesign. Our application of GMP and quality systems proactively derisk design and manufacturing steps, ensuring optimal production and seamless ramp-up. We commit to your timelines, but have our internal quality controls to ensure on-time delivery of your products.
Since 2021, we have manufactured more than 300 different prototype products — averaging around 60 prototypes annually — delivered to customers in 20 countries worldwide. This track record highlights both the scalability and global reach of our manufacturing expertise.
Expertise in Stretchable, Breathable Substrates, Conductive Printing & Medical-Grade Materials
Our manufacturing processes range from rapid prototyping to mass manufacturing – all under one roof. Our vertical integration ensures optimal process-to-process suitability and consistent quality throughout your product’s lifecycle. Our advanced manufacturing capabilities include high-precision Laser and Roll converting, enabling us to produce intricate microfluidic structures in tandem with electrochemical sensors for specialized applications. While all products are different, the quality control – and requirement for consistency – are the same for all products we manufacture.
Do you have a challenging technical problem you are trying to solve? Do not hesitate to reach out.