Industries we Support
Understanding your product regulatory pathways, product risk, design, validation, and helping you with ISO 13485 certification.
Enhancing your ISO certification and breaking into medical device markets with ISO 9001, and ISO 13485 management systems certifications.
Gaining ISO certification in Quality, Safety, and Environmental management systems.
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Helping you understand your obligations with ERAC, EESS, and The ACMA for RCM (c-tick) marking.
About Us
Distinct Compliance Engineering (DCE), part of the Distinct Engineering Group Pty Ltd, offers expert consulting and compliance services tailored to the medical device, manufacturing, and construction industries.
Deep expertise in active medical devices
Regulatory support from strategy to submission
Management System consulting and auditing
Tailored solutions based on your unique business journey
Trust. With decades of industry experience
Why be Distinct
To Empower Businesses by Simplifying Complex Regulatory Landscapes and Providing High-Impact Compliance Solutions.
No matter your industry or goals—whether you're building a new medical device app or need ISO certification to win a government contract—we’re here to help you navigate compliance confidently.
We Create Outcomes That Are Tailored to Your Business Needs, Address Individual Challenges, and Develop Unique, Integrated Solutions
Services we Provide
We help businesses develop and maintain ISO 13485-compliant systems to ensure medical device quality, safety, and regulatory compliance across local and global markets.
Our team supports SaMD development with guidance on classification, risk, and compliance—meeting TGA, FDA, and CE requirements from concept to launch.
We provide clear regulatory pathways and compliance support for TGA, FDA, and CE approvals, helping you streamline submissions and meet global standards.
We assist in creating risk management and clinical evaluation documentation that aligns with ISO 14971 and regulatory expectations for safe, effective products.
We guide construction and manufacturing companies through ISO 9001, 14001, and 45001 certification with tailored systems, audits, and compliance strategies.
We help ensure electrical products meet import/export standards including EESS, ERAC, and ACMA—covering approvals, testing, and regulatory documentation.
Latest CASE STUDIES
Years of Experience
Team members
Successful Projects
Satisfied Clients
pricing plans
Basic Plan
Popularised in the follower with the etraset sheets containing.
Powerful Admin Panel
3 Native Android App
Multi-Language Support
Support via E-mail and Phone
Standard Plan
Popularised in the follower with the etraset sheets containing.
Powerful Admin Panel
3 Native Android App
Multi-Language Support
Support via E-mail and Phone
Premium Plan
Popularised in the follower with the etraset sheets containing.
Powerful Admin Panel
3 Native Android App
Multi-Language Support
Support via E-mail and Phone
Basic Plan
Popularised in the follower with the etraset sheets containing.
Powerful Admin Panel
3 Native Android App
Multi-Language Support
Support via E-mail and Phone
Standard Plan
Popularised in the follower with the etraset sheets containing.
Powerful Admin Panel
3 Native Android App
Multi-Language Support
Support via E-mail and Phone
Premium Plan
Popularised in the follower with the etraset sheets containing.
Powerful Admin Panel
3 Native Android App
Multi-Language Support
Support via E-mail and Phone
Team Members
FAQs
Follow these 6 steps and you’ll get your Help Scout account up and running in no time. If you like to get a full tour of Help Scout and all its features, attend one of our weekly live demos or take a video tour.
Follow these 6 steps and you’ll get your Help Scout account up and running in no time. If you like to get a full tour of Help Scout and all its features, attend one of our weekly live demos or take a video tour.
Follow these 6 steps and you’ll get your Help Scout account up and running in no time. If you like to get a full tour of Help Scout and all its features, attend one of our weekly live demos or take a video tour.
Follow these 6 steps and you’ll get your Help Scout account up and running in no time. If you like to get a full tour of Help Scout and all its features, attend one of our weekly live demos or take a video tour.
Follow these 6 steps and you’ll get your Help Scout account up and running in no time. If you like to get a full tour of Help Scout and all its features, attend one of our weekly live demos or take a video tour.
Latest News
Blog
Reframing Risk as a Strategic Planning Tool While risk is typically associated with negative outcomes, at Distinct Compliance Engineering,
by Admin
July 29, 2025
Blog
If you import, manufacture, or sell electrical devices in Australia, you’ve likely encountered: EESS (Electrical Equipment Safety System) ACMA
by Admin
July 29, 2025
Blog
In the medical device world, Usability Engineering (IEC 62366 – The application of Usability Engineering or its 60601 counterpart
by Admin
July 29, 2025
Testimonials
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President of Sales
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President of Sales
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