Contract Development
At MedRes, we provide advanced contract development solutions. Tailoring our services to each project, we cover the spectrum from initial concept to market approval.
Our expertise encompasses a broad range of technical capabilities and we offer a wide range of products spanning from surgical scopes, energy delivery systems and resectors, to silicone-based devices, to catheters and nitinol medical implants. Choose MedRes for flexible collaboration, customer focus, and efficient design and development.
Contract Manufacturing
At MedRes, we blend top-tier medical device manufacturing with flexibility and cost-effectiveness. Adhering to ISO 13485, FDA guidelines, and Class 8 Cleanroom standards, we serve diverse manufacturing needs, from small to large-scale production.
We leverage competitive pricing and expert talent and offer adaptable production methods, customer-focused manufacturing process development, and in-house fixture and tool design and construction. Specializing in the manufacturing of medical devices and precision medical device components, we remain commited to quality, flexibility and rapid turnaround.
Nitinol and Catheter Expertise
MedRes offers deep expertise in Nitinol to accelerate product development. Our core areas include laser cutting for micro-precision Nitinol components, shape setting with our proprietary ShapeMaker™ System, electropolishing for biocompatible, high-performance surfaces, and comprehensive characterization and testing to ensure real-world reliability across full catheter systems.
Quality and Regulatory Advisory Service
MedRes, with nearly two decades of experience in the medical device sector, emphasizes utmost quality in development and manufacturing, adhering to ISO 13485 and FDA regulations.
We offer comprehensive quality assurance services including the development of quality systems in line with ISO 13485, 21 CFR Part 820 and regional criteria, documentation meeting country-specific market access requirements, and risk management frameworks aligned with ISO 14971. Furthermore, MedRes provides support in qualification and validation processes.
Component Manufacturing
MedRes offers a comprehensive component manufacturing service backed by advanced technology. We excel in producing medical components with utmost precision, facilitated by our state-of-the-art production equipment, metrology lab and expert team.
Our capabilities range from turning, laser cutting, and CNC machining to silicon molding and EDM cutting. Ensuring compliance, our operations align with ISO 9001 standards. With the ability to provide customized solutions, we cater to a range of project sizes. Our commitment lies in delivering quality, flexibility, and cost-efficient solutions, making us a reliable partner in the medical industry.
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Whistleblower protection lawyer, dr. Metzinger Péter – legal@medres-group.com