Scalabe Production for Medical Devices
Whether producing hundreds or hundreds of thousands of units, we select and optimize the right manufacturing approach for your product. All products are tested, assembled, and packaged to meet both customer specifications and regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and IEC 60601. We specialize in regulated product manufacturing, with deep expertise in change control, sourcing, and production.
In addition, we offer design for manufacturability (DFM) consultancy to help optimize product design, improve efficiency, and reduce production costs. For high-volume needs, we provide dedicated manufacturing solutions in collaboration with trusted partners in machine building and automation.
Production under Medical Standards
Operating under ISO 13485 and FDA QMSR (21 CFR Part 820), our manufacturing processes help reduce risk, ensure consistent quality, and support smoother regulatory approvals, enabling faster and more cost-effective market access.
Screentec partners with both established companies and innovative start-ups to solve complex, multidisciplinary manufacturing challenges. By combining deep technical expertise, advanced manufacturing technologies, and robust quality systems, we deliver scalable solutions for medical devices, diagnostics, and other regulated applications.
Our vertically integrated production supports both low-volume manufacturing and high-volume roll-to-roll (R2R) production, allowing a seamless transition from prototyping to mass production. This flexibility enables us to support your product at every stage of development. We emphasize communication, flexilibity, and putting the customer – You – first.
Learn more about how we apply 6S principles in production:
