expertise & Services

Medical Devices

  • Inhalers
  • Vaporizers
  • Implants
  • Disposables
  • Surgical instruments
Kalm Expertise and Services 1

Vaporizer

Device to assist in the internal fixation of IM nails in Orthopedic Procedures. 

Kalm Expertise and Services 2

Our involvement includes building the device specifications, product design and engineering, material selection, building the technical file, establishing and implementing the Quality Assurance System, document control, failure analysis, prototype production, and beta site production.
KALM interfaces with the relevant notified bodies and represents our clients and their products during the initial audit and subsequent regular audits as required. Over the years we have helped our clients achieve ISO9001:2000, ISO13485:2003, and CE approval for their facilities, processes, and products.

Kalm Expertise and Services 3

Handle for insulin Pen Users

Product Design

From Concept through Design, Development and Production
A Wheelchair that has dual configuration: everyday & running

Concept

Kalm Expertise and Services 4

Design

Kalm Projects (16) Custom Made Wheelchair
Kalm Projects (17) Custom Made Wheelchair

Final Product

Kalm Projects (11) Custom Made Wheelchair
Kalm Projects (13) Custom Made Wheelchair

Prototyping, Small Batch Assemblies and Part Production

Procurement, Assembly and Packaging

Kalm Expertise and Services 5

Test Equipment

Medical Valve Life Tester

Kalm Expertise and Services 6
Kalm Expertise and Services 7

Electronic Enclosures

From Design to Production

Kalm Expertise and Services 8
Kalm Expertise and Services 9

Production Tools

Welding Jig for Production of Highly Accurate Assembly

Kalm Expertise and Services 10

Project Planning and Management

Including:

  • Proof of Concept & Experimentation
  • Innovation Strategy
  • Prototyping
  • Supplier Selection & Procurement
  • Risk analysis
  • Documentation
  • Product Ergonomics Optimization
  • Product Testing & Accelerated Life Testing
  • Manufacturing Support & Process Optimization
  • Engineering & Technical Consulting

Production Improvement

Multi-Cooker

Original Product

Kalm Expertise and Services 12

Design of Face

Kalm Expertise and Services 11

Prototyping and Testing

Kalm Expertise and Services 13

Final Product

Kalm Projects (2) CHEF iQ Smart Cooker hero