British medical device expert proposes implant rules to define a non-active surgical implant as optimum or ideal
An article written by an international expert in US and European medical device regulations, Mr Haroon Atchia, explores the fundamental properties and characteristics of non-active surgical implants, and proposes implant rules from which concepts of optimum physiological function and implant potential, respectively, are proposed.
London, 27 February 2018
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article on “Properties and Characteristics of an Optimum / Ideal Non-active Surgical Implant”. The article, published today in the Journal of Medical Implants and Surgery, explores the fundamentals of non-active surgical implants, their properties and characteristics. The implant rules deduced from implant potential might help to promote uniform, scientific assessment and comparison.
“Definitions governing medical devices given in leading geo-political regulatory domains are insufficient to specify the fundamental attributes of non-active surgical implants. Equally, voluntary, non-majoritarian, goal-oriented standards on non-active surgical implants are devoid of fundamental attributes of such products. The rules we propose might even improve standards on, or relevant to, non-active surgical implants published by standard organisations”, states H Atchia.
The article may be requested from QFI, email firstname.lastname@example.org, reference: Atchia, H: “Properties and Characteristics of an Optimum / Ideal Non-active Surgical Implant”, February 2018 | Quality First International.
About Quality First International (QFI)
QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.