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ISO 13485:2016 Certification

Thursday 19th October 2017

Our new state-of-the-art ISO class 7 cleanroom facility has been certified to ISO 13485:2016. The latest certification represents a significant step forward from the previous issue of the standard and contains more exacting requirements for the medical packaging sector. In addition, the certification meets and exceeds the requirements of ISO 9001 derivatives, enabling competitive advantage, and offering non-medical device clients much greater product confidence.

Products manufactured include custom thermoformed handling trays, suitable for high-speed production with automated assembly and transit for a range of products including: Handling trays for auto-injectors, dry powder inhalers, injection moulded components, prefilled syringes, pharmaceutical bottles and medical electronics. Other medical packaging solutions available include trays, procedure sets, clamshells, tubs, skin pack sets, covers, lids, sterile barrier blisters and seal blisters. And, being part of TEQ, supply is available to both European and Global customers.

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