QARA Associates Ltd
QARA Associates Ltd is a Welsh company offering specialist quality and regulatory support. We can offer different levels of support depending on your requirements such as providing expert advice and guidance to your staff or we can do all the work for you, giving you piece of mind that your regulatory compliance is in safe hands.
QARA Associates can help you successfully CE mark your products and maintain your ongoing regulatory compliance. We can support your transition to the MDR/IVDR, including Technical File remediation and oversee your post market and vigilance activities.
We specialise in ensuring clients establish and maintain a lean and compliant quality management system, including ISO 13485:2016, FDA 21 CFR 820 and MDSAP and lead your problem solving and quality improvement activities. We also offer a range of training solutions, including coaching and mentoring.