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DirectoryIndustryMedical Technology IndustrySteinhausenLemax GmbH
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Lemax GmbH

Summary

About the company

Lemax GmbH provides development, industrialization, CAPA process support, project management and validation services for Class I, II, III and AIMD medical devices. It supports product realization and market introduction via design and process qualification, risk analysis, technical file compilation and prototype sourcing, and offers expertise in manufacturing and special processes such as injection molding of implant‑grade plastics, machining, thermoforming, extrusion, coatings, sterilization and packaging, MEMS and PCB assembly, and contract manufacturing.

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Products & services

Industry:Medical Technology Industry
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Product Development
Product development for medical devices in classes II, III and AIMD, including design, design qualification, validation, risk assessment, and selection of suitable partners and solutions.
Industrialisation
Industrialisation for medical devices, including supplier qualification, development of production facilities, design specification, work instructions, as well as process qualification and validation.
CAPA Process Support
Support with process, supplier and design issues, including root cause analysis, implementation and verification of corrective actions, as well as qualification and validation.
Project Management
Project management for medical devices, including feasibility studies, concept and design assessment, material and coating definitions, CE documentation, risk assessment, and prototype procurement.
Validation
Validation and qualification of processes, including SOPs, user requirements, specifications, validation master plans, qualification plans and reports, as well as requalifications.

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Location

Eschfeldstrasse 3
6312 Steinhausen

At a glance

Legal form
Limited Liability Company
UID
CHE-113.800.631
Founded
2007 · 19 years
Last commercial register change
May 20, 2010
Employees
1 to 10

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