New article on the design principles of electrical surgical instruments

22 June 2021

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.

Electro surgical instrument

“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.

New Guidance: Understand how to apply general personal data protection to medical devices to avoid non-compliance and fines

9 June 2021

Quality First International has published a guidance book to raise awareness and preparedness of medical device manufacturers with regard to Regulation (EU) 2016/679, encompassing additional elements of the UK Data Protection Act 2018. This sector-specific guidance has been developed to help manufacturers understand and apply personal data protection obligations in the medical devices’ area.

London-based medical device regulatory consultancy Quality First International (QFI) has published a Medical Device Guidance Book: Guidance on application of Regulation (EU) 2016/679 on data protection to medical devices in the European Union and United Kingdom – Understanding and practice to help manufacturers achieve compliance with the pertinent regulations in the European Union and the United Kingdom.

“The guidance is motivated by recognition that the medical device sector is generally oblivious or cavalier about personal data protection and therefore might be ill-equipped to comply; or worse, exposed to enforcement that could otherwise be avoided easily.”, says Haroon Atchia, CEO and co-founder of QFI. “Fines can be huge for non-compliance with the regulations and this guidance can be used to apply the regulations to improve understanding and practice in the area of general personal data protection.”

The guidance book is available from QFI upon request, please contact [email protected]. 178 pages, PDF, Price: 249 GBP.