The Wasdell Group, an outsourcing partner to companies in the pharmaceutical and biotech sector, has seen its Dundalk facility certified with the ISO 13485 standard for medical device manufacturing. 

The ISO 13485 is an internationally recognised certification, ensuring that the company’s quality management system complies to customer and applicable regulatory requirements.

Earlier this year, The Wasdell Group acquired a 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 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.

Graham Wright, managing director of PPFL said: “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.”

Vincent Dunne, CEO at Wasdell, added: “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.”

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.