Why you need ISO 13485 for your medical device manufacturing project

Why you need ISO 13485 for your medical device manufacturing project?

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ISO13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

To attain this prestigious certification, we were audited by the independent firm TÜV Rhineland according to several important criteria.

- Risk Management
- Clarification of Management Responsibilities
- Enhanced Training
- Facility Improvements
- Design and Development
- Control of Suppliers

We are prepared to support you when it's time to bring your medical devices to market fast.

Our international team of engineers and technicians are dedicated to making your custom parts using the most advanced equipment and techniques including Plastic Injection Molding, CNC Machining, Pressure Die Casting, 3D Printing and Vacuum Casting. We also offer various detailed finishing services.

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