The Wasdell Group has announced that its Dundalk, Ireland facility has been certified to comply with the ISO 13485 standard for medical device manufacturing.
The ISO 13485 is an internationally recognized certification, ensuring that the company’s quality management system complies to customer and applicable regulatory requirements.
Earlier this year, The Wasdell Group acquired a specialist packaging supplier to the medical device and pharmaceutical sectors, Planned Packaging Films Limited (PPFL).
Planned Packaging brought over 40 years’ experience to The Wasdell Group, supplying leading global medical device manufacturers and pharmaceutical companies in the UK, Europe and the Americas. The ISO standard will further strengthen this offering by providing a base for PPFL services in Ireland.
“We are delighted that we now have a base in Ireland that can support our continued growth in the medical packaging sector within the UK and Ireland, as well as our export markets,” Graham Wright, Managing Director of PPFL said.
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“Achieving the ISO 13485 certification allows us to meet the growing needs of customers requiring the medical device standard. It also positions us to support the supply of films and components to existing customers following our acquisition of PPFL that enabled our entry into this space,” Vincent Dunne, CEO at Wasdell, said.
The Wasdell Group already services the European pharmaceutical and biotech sectors from Dundalk with both clinical and commercial packing in a wide variety of packaging formats, including syringes, blisters, containers and sachets.
The Wasdell Group offers end-to-end services across pharmaceutical manufacturing, packaging and storage and distribution.