Vitalograph successfully passes MHRA and FDA audits

Vitalograph has passed its first routine inspection by The Medicines and Healthcare products Regulatory Agency (MHRA) with flying colours. The Agency reported zero critical findings, zero major findings and only a handful of observations. We, at Vitalograph are delighted to be one of only 5% of CROs to pass with this degree of success. "The results of our MHRA audit in October confirms that our systems and processes, established over many years experience in respiratory clinical trials, meet the high standards of best practice demanded by this rigorous regulatory environment" says Vitalograph Clinical Trials Director, Lewis Weidman.

Last year’s FDA audit of the Vitalograph research and manufacturing facility in Ennis, Ireland was also a great success, with zero deficiencies (483’s) raised. "It is very rewarding to see the investment and planning that has gone into building excellence into our Ireland plant reflected in this excellent FDA audit result. Coupled with our ISO and CE certifications for medical devices design and manufacturing, it shows our commitment to quality at all levels of our organisation" says Vitalograph Regulatory Affairs/QA Manager, Tom J Healy.

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