Medical Devices Consultants
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DISTINCT COMPLIANCEENGINEERINGFor engineered technical solutionsLEARN MORE ABOUT US
Distinct Compliance Engineering
ABOUT WHO WE ARE
Distinct Compliance Engineering is a dynamic engineering consulting group committed to providing quality technical and compliance initiatives tailored to your products and organisation.
Our team develop solutions for the medical device, pharmaceutical, manufacturing, import/export, textile, construction, and service industries to the likes of ISO standards compliance and auditing, usability engineering, CE certification guidance, EESS/ERAC guidance, ACMA requirements, risk assessment works, supplier audits and more.
INDUSTRY SECTORS
OUR CLIENTS
WHAT OUR CLIENTS SAY
Working with Distinct Compliance Engineering gives us a great resources for technical understanding of devices and standards. Their “outside the box” thinking provides unique simplified solutions.George Liozou
We have used the team at Distinct on a number of projects, which have included validation, sensitive large scale equipment moves and compliance auditing. We value their methods as they increase our knowledge base by bringing in outside ideas and concepts that allow us to benchmark against industry standards.Judy Andrews
LATEST BLOGS
Importing from China – Some real considerations
The current economy makes turning to China for goods worthwhile. Even with manufacturing and custom parts, China organisations are more than willing to accept low MOQ’s to increase trade. All these things make it appealing for smaller businesses (and large ones alike) to turn to our Chinese friends for services and goods. However, there are…
Make use of Usability. How to get it right… and wrong.
In the medical device world, Usability Engineering (IEC62366 The application of Usability Engineering or its 60601 counterpart IEC60601-1-6) is a required tool within the validation of a medical device. Regardless of if it’s, software, active, or IDV, Usability engineering helps us understand how the device (or system) react within a real-world application. It draws from the…
Equipment Electrical Safety Compliance – What changed?
If you are in the business of importing, manufacturing, and ultimately selling electrical devices within Australian markets then, no doubt, you’ve come across the EESS (Electrical Equipment Safety System), ACMA (Australian Communication and Media Authority) requirements for electrical safety and EMC compliance as well as Electricity Safety (Equipment Safety Scheme) Regulations. Now, navigating your way…