Design and building of production tools and test equipment.
Review of products and production processes from the operations and mechanical engineering perspectives; inorder to improve the product and reduce costs.
Constructing Production Files to meet ISO9000, ISO13485, CE, and FDA requirements in English and/or Hebrew.
Carrying out risk analysis using the Failure Mode Evaluation Analysis (FMEA) methodology.
Evaluation and selection of suppliers.
Project Planing & Management
KALM designs and builds medical devices and consumer products. Our services include defining product requirements, material selection, development, engineering, building of prototypes, tooling, documentation and overseeing beta site production.
Prototyping - Zero Series
KALM provides prototyping and Zero Series (small scale production) through our selected suppliers.
Supplier Selection
KALM assists in the selection and evaluation of suppliers.
Production Tools
KALM designs and builds production tools including electronic enclosures and jigs with an emphasis on ergonomics and operator safety.
Test Equipment
KALM designs and builds test equipment to MIL and ISO standards and client requirements.
Documentation
KALM produces drawings and production files to meet ISO9001:2015, ISO13485:2003, CE and FDA requirements in English and/or Hebrew, as well as machine and product operating manuals.
Risk Analysis
KALM performs risk analysis using the Failure Mode Evaluation Analysis (FMEA) methodology.
Product Improvement
KALM analyzes products and production processes from the operations and mechanical engineering perspectives in order to improve the products and reduce costs.