Michael Gourlay is CLM Training’s expert in the field of Medical Devices.

Michael has vast experience in providing device and lab assessments based around the ISO 13485 and ISO 17025 standards as well as expertise in the definition and application of CE Marking standards across the medical sector.

His approach is highly client oriented.

“I want my customers to attain self-maintaining quality systems so they don’t have to keep calling me back. This means our upfront work needs to be particularly rigorous. My inspections are very detailed and I put a lot of work into developing the processes and developing the client manuals. But it pays off. My clients have been able to maintain the highest possible quality standards virtually indefinitely.”

Michael can provide direct assessments and quality management system builds or work with to develop customised training programmes on, for instance, lead auditing.

He has worked for organisations around the world and is happy to work with both corporates and start-ups. He is a qualified QMS Lead Assessor and has lectured in the IQA diploma.

Michael’s has experience in the following quality standards. ISO 9001:2000, BS EN 46001, ISO 13485:2003, FDA 510(k) submissions, ISO 14001, QS9000, TS 157/AS 9100 CE Mark medical devices, TQM, and Quality Systems Documentation.

Contact CLM today to discuss your lab assessment and CE marking requirements.