Brisbane, Australia- IntelliDesign, one of Australia’s leading electronics design and manufacturing companies, is proud to announce that it has achieved ISO 13485:2016 certification, a globally recognized standard for quality management systems in the medical device industry.
This certification underscores IntelliDesign’s unwavering commitment to the highest standards of quality, safety, and regulatory compliance in the design, development, and manufacturing of medical devices. The company was originally founded in medical device development as IntelliMed and has been manufacturing medical devices for global customers for more than 20 years. This is a return to roots for the company and the ISO13485 certification strengthens our commitment to expanding our service offering for medical device development and manufacture.
IntelliDesign, a privately owned, Brisbane-based business, has been a trusted name in high end electronics design and manufacturing for 30 years. The company employs more than 130 professionals, focused on designing and manufacturing game-changing products for mission critical and physically demanding environments. IntelliDesign manufactures over 60,000 electronic products per year at its Brisbane facility
“Achieving ISO 13485 certification is a significant milestone for our team,” said Matt Bromwich CEO of IntelliDesign. “It demonstrates our dedication to consistently meeting customer and regulatory requirements and reinforces the trust our partners and clients place in us every day.”
ISO 13485 is the internationally recognized standard for quality management systems specific to the medical device industry, ensuring organisations consistently produce safe and effective products that meet both customer expectations and applicable regulatory requirements. The rigorous certification process involved a comprehensive audit of IntelliDesign’s quality management system with the process taking over 2 years to complete.
With this certification, IntelliDesign is better positioned to serve its customers in global markets, strengthen its operational efficiencies, and pursue new opportunities in the healthcare and life sciences sectors.
IntelliDesign is the only company in Australia to hold both ISO 13485:2016 and AS9100D (quality management system tailored for aerospace, aviation, space and defence industries) for Design and Manufacture.
For more information about IntelliDesign and its quality-driven approach to medical device design and manufacturing, please visit www.intellidesign.com.au
Media Contact
Matt Bromwich CEO
07 3716 7000
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