Medical Device Manufacturing Capabilities
As a CDMO for medical devices and their components, we combine prototype agility with high‑volume manufacturing capability. Whether you need contract manufacturing for few hundreds or hundreds of thousands of units, Screentec selects and optimizes the right approach for your project. We offer:
- – Screen printing, hybrid electronics, assembly and packaging for complex regulated products
- – Design for manufacturability (DFM) consultancy to optimize product design, improve efficiency, and reduce costs
- – Validation and pilot production to de‑risk scale‑up before volume runs
- – Dedicated high‑volume solutions in collaboration with trusted partners in machine building and automation
All devices 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.
Our Quality and Requlatory Framework
Operating under ISO 13485 certification and FDA QMSR (21 CFR Part 820), our quality and regulatory framework is designed to reduce risk, ensure consistent quality and support smoother approvals. We integrate verification, validation and traceability into every stage of production, so you receive consistent, audit‑ready documentation and reduced time‑to‑market.
From Concept to Commercial Production: Our Manufacturing Process
Screentec supports both established companies and innovative start-ups with end-to-end manufacturing solutions. As a medical device contract manufacturer, we combine technical capability, regulatory expertise and scalable capacity to bring regulated products to market efficiently.
Our vertically integrated process supports our clients from concept to high‑volume production:
- Prototyping and DFM: Early collaboration with your engineers to refine designs for scalable manufacturing and regulatory readiness.
- Pilot and Validation Runs: Low‑volume production with full documentation to validate functionality, manufacturability and compliance.
- Scaling and Roll‑to‑Roll Manufacturing: Transition to high‑volume roll‑to‑roll manufacturing or automated hybrid processes without changing suppliers.
- Ongoing Optimization and Support: Continuous improvement, supply‑chain management and regulatory partnership to keep your products competitive and compliant.
Throughout this process we emphasize communication, flexibility, and putting you – the customer – first.
Quality Built on 6S Principles
Screentec’s production environment is organized around the 6S principles—Sort, Set in Order, Shine, Standardize, Sustain and Safety. These practices provide the contamination control, organization and process consistency required for ISO 13485 contract manufacturing and FDA QMSR compliant manufacturing. They underpin our commitment to quality and efficiency.
Learn more about how 6S principles support our quality systems:
Ready to discuss your production requirements? Contact our manufacturing team to schedule a feasibility consultation and learn how Screentec can support your product from prototype to commercial scale.