Our protocols are proven and valued by consumers and patients.

Medical Device Design

Medical Device Design Starts with Human Factors

Our process and dedication to quality make us a perfect fit to develop new cutting edge product for the medical and biological fields.

Biology Analytics Machines

Therapeutic Devices

Surgical Tools and Equipment

Prosthetics and Assistive Wearables

Medical device design

TOOL follows a strict protocol with each and every client to ensure products we design will be safe and user friendly for medical workers or patients.

Quality Management System

Quality management system

Our Commitment to Excellence

Regulatory Strategy

User/Patient Safety

Testing Requirements

Regulatory Choices


Quality Assurance

Document Control


Risk Management

Design History Files

Device Master Record

Accountability through QMS System

Reach out to us for our certificate +


Medical to Market

We practice clean product design through enhanced etiquette to find solutions that are economical and environmentally conscious. Every project is guided through our process with a goal to maintain the smallest footprint during and after the development.

UL and CE Certifications

Design Change Control Orders

Part Inspection

Production Documentation Packages

IEC 60601


Let's get you on the right tack.