Materials used in medical technology often need to be classified and approved according to existing regulatory requirements. Some plastics meet requirements for medical use, so-called biocompatible plastics, for use up to 24h body contact.
Carlsson & Möller has knowledge of regulatory requirements and provides the majority of materials with biocompatibility according to ISO 10993, USP, VI, AOF, FDA etc.
A specific assortment of plastics meets requirements to be used in vivo, i.e. as implants.
The above requires knowledge of regulatory requirements, selection of suitable materials and restrictions around these.
Carlsson & Möller has long and extensive experience with construction plastics in medical technology applications. We offer qualified technical support and advice – from concept development and material selection to processing and refinement of finished products.
Our LSG (Life Science Grade) materials and refined details can be delivered with full traceability according to SS EN 10204 if necessary.
Our production includes advanced processing machines with which we process material to finished detail with high quality and surface finish requirements.
With flexibility, we can economically manufacture single prototypes and short series as well as larger series.
By only processing plastic materials with non-animal cutting fluids, we ensure a clean production without contamination risks.
Carlsson & Möller can also be responsible for the assembly of various details and components as well as deliver completely finished products ready for final assembly.
With our new clean room ISO class 8 (class 7), we offer washing, assembly and packing in a controlled, clean environment.
