With collectively 100+ years of Medical Device Manufacturing and Regulatory experience, the team at Sterile Management Systems Ltd are perfectly placed to help you with your business needs
18+ years’ experience in manufacturing, most of which relate to Medical Device Regulatory Affairs. Jack is an ex-Notified Body Auditor and holds a bachelor’s degree in life sciences, has specific experience of sterilisation and sterile barrier systems. Jack is not only the founder and director of SMS; he also is co-founder of certification body S.A.L. and EU Rep company MediReps
Many years’ experiences in the administration of regulatory affairs and medical device quality management, Henrietta has worked for leading device manufacturers. Her role as administration manager at SMS includes coordination of training and events as well as financial responsibilities.
With almost 40 years of working history in medical device and quality management roles, Annette is responsible for development and delivery of external bespoke training at SMS often working in collaboration with industry recognised training organisations. Having gained her degree in Microbiology with Genetics as well as being an ex-Notified Body Auditor. Annette is highly experienced with sterilisation of medical devices and regulatory consultancy
Quality & Regulatory Consultant
30+ years’ experience within medical device manufacturing, specifically within Quality Management,. Dawn is an experienced project manager having completed open university qualification in this field, she is also PRRC for multiple SMS clients within her role as quality and regulatory consultant.
Quality & Regulatory Associate
9+ years’ experience within quality management roles at various manufacturers, Sam has a BSc (Hons) degree in Forensic Science & Anthropology. She is particularly experienced with regulatory affairs and QMS for class I & IIa + Class IIb implantable medical devices