‘Culture Media, Solutions, and Systems in Human ART’, a pioneering volume of authoritative articles looking at current issues within the area of assistive reproductive technologies (ART) features a chapter written by Theresa Jeary, LRQA’s Technical Manager within the medical directives team.
Theresa examines the international regulations governing the approval of the fluid products that are used for the storage of sperm and oocytes prior to fertilisation and the growth media that supports the growth of embryos prior to implantation during in-vitro fertilisation (IVF) procedures. Prior to 2008, these products were unregulated in Europe, and Theresa was actively involved in the European discussions to define the quality assurance and regulatory pathway that led to the classification of these products as medical devices.
In her article, 'International regulation of ART media’ Theresa looks at the current guidance regarding the classification of IVF media under the Medical Device Directive, the CE Marking process for approval in Europe and an overview of global approvals processes for such products.
Theresa comments: “This volume contains contributions from leading practitioners within this field and is set to become an invaluable guide for all those working within this vital sector of medicine”.
Edited by Patrick Quinn, a highly respected reproductive biologist, the publication has pulled together respected authorities from across the ART sector, to address the key issues affecting practitioners working in the area of reproductive biology today.
“It is a key tool in helping share best practice globally which will further the work in supporting and transforming the lives of infertile and subfertile couples everywhere,” Theresa concludes.
This comprehensive guide will be invaluable reading for embryologists, doctors, healthcare personnel working in human assistive reproductive medicine to better the safety and effectiveness of this treatment.
For medical device manufacturers involved in the development and manufacture of the next generation of media products used in ART, the publication provides a comprehensive guide on the global regulatory approvals process and quality managements systems expectations involved in obtaining market approval.
The book was published earlier this year and is available in paperback or for Kindles from Amazon and directly from the publishers, Cambridge University Press.