Alcis - Our Design And Regulatory Affairs Prestations

Our Prestations

An idea, a need

A concept, a patent

A model, a device

You have

Physician, surgeon

User

Subcontractant

Manufacturer

Distributor


You are

to develop and/or to mark CE and/or manufacture a medical device (catheter, probe, active implant, in vitro diagnostic device, machinery, instrumentation...),

to market a medical device by relieving the constraints of quality managment.


You want


ALCIS proposes subcontracting prestations to relieve customers from specific skills that are no theirs or to optimize the logistic of manufacturing. This subcontracting prestations realized for you can be: assembly by laser welding, silicon injection molding, packaging of medical devices. This prestations are realized under controlled atmosphère in clean room of class ISO 5 & 7)			ALCIS proposes a global offer of services, studies or consulting to market your device. From the design to the CE marking, development, industrialization and homologation of your device is realized in collaboration with Alcis. Our prestations are realized in order to complete the skills of its customers and partners, to achieve success. ALCIS may also, once your device on the market, unload you from quality and regulatory constraints.


Our experience


Active medical implants: - cardiac surgery - digestive surgery Non active medical implants: - articulations surgery - central vascular surgery - minimally invasive cardiac surgery - obésity surgery Various devices: - micro ambulatory antenna for MRI - enema machine for digestive surgery - cells purifying kit - machine for in vitro giagnostic

Alcis - Our Design And Regulatory Affairs Prestations
Our prestations of : design and regulatory affairs, subcontracting : laser welding, silicon injection and packaging
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