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 provides rapid prototyping and flexible, scalable production.

We tailor our medical product development and manufacturing services to each stage of the product lifecycle, ensuring full compliance with ISO 13485:2016 and FDA QMSR (21 CFR Part 820).

Our expertise is especially suited for complex, high-performance applications, such as wearable devices and advanced diagnostics, where integration, signal quality, and usability are critical. All solutions are developed and manufactured efficiently under one roof.

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 Breathable, Stretchable Substrates, Conductive Printing & Medical-Grade Materials

Our manufacturing capabilities span from rapid prototyping to high-volume production — all under one roof. Our vertically integrated processes ensure seamless transitions between production stages, delivering consistent quality throughout the entire product lifecycle. We utilize advanced technologies such as high-precision laser and roll-to-roll converting to produce intricate microfluidic structures alongside electrochemical sensors for demanding applications.

While each product is unique, the quality control – and requirement for consistency – remain 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.

CONTACT US