Quality First International has published an article that examines the difficulties in analysing antecedent medical device technology used in modern medicine against new or evolving regulations.
London-based medical device regulatory consultancy Quality First International (QFI) has published an article: Electrical surgical instrument design principles to help manufacturers understand the importance of clear and categorical assessment of design principles in electrical surgical instruments by highlighting the general deficiencies of, and problems arising from, poor design considerations. The article then identifies factors to consider in the development of the optimum design for these instruments.
“Electrical surgical instruments were invented decades ago. Design principles were never elaborated, and very little thematic or phenomenological research is published on this subject”, says author Haroon Atchia, CEO and co-founder of QFI. “The article elaborates relevant medical device regulatory conformity assessment issues a specialist encounters when evaluating antecedent products, with a particular focus on electrical surgical instruments”.
The article is available here for free download. 4 pages.
About Quality First International (QFI)
QFI is a London-based medical device 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. 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.