Test Labs has emerged as the sole UK laboratory accredited to conduct reprocessing procedure tests for medical devices.
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This recognition comes as the company continues its growth, expanding its scope of testing services to cater to the evolving needs of medical device manufacturers, while navigating the complexities of the regulatory landscape.
Medical device manufacturers face stringent regulatory requirements to ensure the safety and compliance of their reusable products. One crucial aspect involves validating the cleaning, disinfection, and sterilisation processes outlined in the instructions for use (IFU).
This indispensable data is pivotal in applications for regulatory approval, as it demonstrates the device’s adherence to patient safety standards and the effective minimisation of infection risks.
Recognising the growing demand for accurate and reliable testing services, Test Labs invested substantially to develop and implement technical procedures, extending its ISO 17025 scope to encompass tests associated with device reprocessing. The expansion is a testament to the company’s unwavering commitment to quality and its dedication to providing comprehensive reassurance to customers.
Enrico Allegra, Test Labs’ laboratory manager, said: “We take immense pride in supporting our customers amid the ever-changing regulatory landscape, offering them UKAS accredited reports for validating their reprocessing instructions.”
Toni Carlton, head of QMS, said this advancement was a major stride in assisting customers to adapt to regulatory changes, particularly the MDR reclassification. She emphasised the significance of UKAS accreditation as a symbol of confidence and reliability, providing manufacturers with much-needed assurance during uncertain times.
Amid mounting pressure on manufacturers to meet evolving regulatory standards, Test Labs’ accreditation emerges as a symbol of reliability.
As the medical device industry faces continuous advancements and challenges, Test Labs remains steadfast in its dedication to providing exceptional testing services, bolstering the sector’s resilience, and advancing patient safety.