Medical Devices & Diagnostics
At CAD-IT Australia, we specialise in delivering tailored digital solutions designed to address the unique challenges faced by the life science sector. Our bespoke solutions bring significant advantages to you by streamlining regulatory compliance and quality management, real-time monitoring in manufacturing and smooth data management in R&D.
Our solutions accelerate time to market, drive cost savings, and enhance overall business efficiency.
Our experienced team of professionals works closely with you, offering strategic guidance and hands-on assistance to drive success throughout the whole journey.
Together let’s revolutionise the future of healthcare, improve patient outcomes, and shape the life science landscape.
Our solutions support all life science related industries, including Medical Device, Pharmaceuticals, and combination products. We have the expertise to tackle any obstacle in a 100% compliant environment.
Life Science Specific Windchill Templates:
comply with ISO 13485/FDA CFR 21 Part 820
comply with ISO 9001
comply with FDA CFR 21 Part 11
Quality – Audit, Complaints, Non-conformances, CAPA/SCAR
Creo: Design The Way It Should Be
Accelerate innovation with powerful, proven functionality and transformative new technologies. Iterate faster, reduce costs, improve quality, and gain market share with Creo.
Pre-configured templates include:
Medical Software Engineering (including FMEA templates, compliant with EU MDR, US FDA regulations, IEC 82304-1,
IEC 62304, ISO 14971, FDA CFR 21 Part 11 & 820).
GAMP 5 (Good Automated Manufacturing Practice, V5) for project validation and quality risk management
Validation Package Kit
Medical Audit CAPA – ISO 13485, FDA CFR 21 part 820
Life Science Specific Tulip pre-configurations:
GxP Ready, FDA 21 CFR part 11, EU GMP annex 11, ISO 9001, GAMP5
Prensilia and Elastico Disegno bring functionality and aesthetics to robotic prosthetics with HP Multi Jet Fusion technology.
Gedeon Richter selected codeBeamer ALM to manage the testing, documentation, and validation of its computerized pharma manufacturing process control & automation systems.
“All our development employees now use codeBeamer ALM. But we don’t just use it for software development: managers, Quality Assurance specialists, and others stakeholders now use codeBeamer ALM for various tasks throughout the whole process of development.”
Medtronic has implemented codeBeamer ALM to overcome issues that their previous software ecosystem wasn’t able to efficiently address.
Bigfoot Biomedical selected and implemented codeBeamer ALM to support their medical device development processes.
Laerdal Medical built a unique and powerful solution with Tulip vision to ensure all parts of assembled kits are complete before shipping to customer sites.
Transforming processes to minimise costs and improve efficiency whilst maintaining ISO standards