This marks a major milestone for the company as it expands into certified medical device manufacturing, specialising in medical wet wipes, tissues, and sachets containing liquid or cream solutions.
A New Chapter in Medical Manufacturing
The new certification underscores Guardpack’s commitment to safety, consistency, and continuous improvement. With ISO 13485 now in place, the company can formally supply healthcare and medical sector clients with essential, single-use products for:
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Disinfection of medical devices
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Wound and stoma cleaning
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Skin preparation prior to procedures
These items are crucial for infection prevention and patient safety, placing Guardpack at the forefront of modern healthcare product manufacturing.
Commitment to Quality and Growth
Jeremy Freedman, Managing Director at Guardpack, commented:
“Achieving ISO 13485 is a significant step forward for us. It highlights our dedication to continual improvement, robust quality systems, and builds on our established partnerships in the healthcare sector while opening exciting new opportunities.”
The ISO 13485 certification now enables Guardpack to partner with OEMs, hospitals, pharmacies, and medical distributors who demand stringent quality, risk management, and documentation processes to guarantee product safety and reliability.
Backed by Industry Support
This achievement follows Guardpack’s successful participation in Anglia Ruskin University’s Arise ABOVE Programme (2024), which offered critical funding and support during the company’s transition into medical manufacturing. The programme enabled Guardpack to conduct a thorough gap analysis and implement a comprehensive quality management system (QMS) — key components in achieving regulatory compliance and positioning the company for future growth.
Strengthening an Already Robust Certification Portfolio
Guardpack already holds ISO 9001:2015 (Quality Management) and ISO 14001:2015 (Environmental Management) certifications. The addition of ISO 13485 further reinforces its status as a trusted manufacturing partner to the healthcare industry.
