Seb Clerkin is a results driven leader in the medical device industry. He has extensive knowledge in the area of Medical Device Regulations and Quality Management Systems. He has expertise in developing strategies for new product introductions, process remediation, QMS implementation and regulatory submissions.
Seb Clerkin is a faculty member of the Association for the Advancement of Medical Instrumentation (AAMI) where he provides training to Industry and FDA.
He is an IRCA certified lead auditor and provides auditing services to multiple clients. He has published articles in peer-reviewed journals on topics such as cleaning validation.
He is Regulatory Affairs Certified in EU regulations and has a keen understanding of EU MDR.
He has a PhD from the University of Bristol, which involved studying the toxicological and biological effects of prosthetic implants, and is a member of AAMI and RAPS.
GMP Advisory Services was established by Seb Clerkin in 2009 to provide regulatory and validation expertise to the medical device industry. We support our clients in complying with the regulations and the relevant ISO standards.
GMP advisory services has developed a highly competent and experienced team that is available to meet client requirements. We match our team members against our client’s needs, making sure we have the right personnel for the job.