Medical

Plastitel, medical market partner

An organization with an in-house team dedicated to the medical sector

Plastitel offers its medical sector customers an impressive section with dedicated resources and testing plans:

• Leak testing
• Tension testing
• Assembly
• Tests on all manufactured goods

The evolution of plastic materials allows our customers to obtain materials which are more and more versatile.

Tailored controls adapted to the requirements of the medical sector

Thanks to our extensive knowledge of medical sector specifications, our customers are guaranteed to receive quality products.

Benefits of working with Plastitel in the medical sector:

• Risk mitigation,
• Respecting FMECA (Failure mode, effects and criticality analysis)

An accreditation which ensures efficiency of our processes for the medical sector

ISO 13485:2003 details the requirements within a quality management system framework where an organization wants to validate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The objective of ISO 13485:2003 is to facilitate the implementation of regulatory requirements for medical devices within the quality management system framework. It therefore includes specific requirements for medical devices, no matter the type or size of organization.

Currently undergoing ISO 13485 accreditation.

(Source: www.iso.org)

Raw materials specific to the medical sector

Plastitel enables you to benefit from its experience working with materials which are compliant to ABS-PC/KYDEX specific standards and UL94-V0 flammability standards. Plastitel is one of the few manufacturers able to offer TPU (Thermo Plastic Urethane) thermoformed products.

Plastitel is a preferred partner in the development of plastic components for all categories. From simple component coating to complex parts shaped in various forms, Plastitel has the expertise to guide you to an advantageous solution.