Summary overview of the entire CE Marking process

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Short Bio for Richard Hall:

With 24 years’ experience of quality management within the medical device and IVD industries, Richard Hall, Director and Founder of QMS Consultancy Ltd is well placed to offer professional consultancy and business acumen. The company provides expert consulting services to assist companies worldwide achieve their Quality and Regulatory goals of gaining ISO 13485 and CE Mark accreditations.

Richard’s career includes senior management positions in both New Product Development and QA/RA within the IVD and Medical Device industries. IVD experience includes diabetes, osteoporosis, helicobacter pylori and sexual health, including professional, over the counter and self-test products. Medical device experience includes urinary care, wound care (alginate, hydrocolloid, film, gel), blood coagulopathy, ECG, TENS, stents, tourniquets, stand-alone-software and multiple orthopaedic products.

Richard, a trained Lead Auditor himself, has been the company contact for more than 40 Notified Body audits and therefore understands what is required to pass an ISO 13485 assessment. Richard has also written product Technical Files for Medical Devices and has successfully gained the CE mark for multiple devices.