Understanding the Black Sheep of Standards: An Analysis of EN ISO 14630 on Non-Active Surgical Implants and Practicalities of Its Application
An eBook on the standard EN ISO 14630 written by Haroon Atchia analyses the controversial standard on non-active surgical implants whose latest version from 2012 is considered non compliant with the relevant legal requirements (Article 10. 6 of Regulation (EU) No 1025/2012) by the European Commission.
London, United Kingdom, December 07, 2017 --(PR.com)-- Haroon Atchia, CEO of the London-based medical device regulatory consultancy Quality First International, has written a profound analysis on the controversial standard EN ISO 14630 on non-active surgical implants whose latest version from 2012 is considered non compliant with the relevant legal requirements (Article 10. 6 of Regulation (EU) No 1025/2012) by the European Commission.
“It is hoped our research will assist manufacturers in understanding EN ISO 14630 more fully, including areas causing problems to the industry and offer recommendations on how conformity assessment can be managed. Additionally, results of our research could aid developers of the standard and support assessment of its adequacy by legislation,” says Haroon Atchia.
The table of contents is available on the QFI website at www.qualityfirstint.com.
The eBook may be requested from QFI by email to marija@qualityfirstint.com.
Price: $599 (plus VAT as applicable), 406 pages including covers, provided in PDF format.
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.
“It is hoped our research will assist manufacturers in understanding EN ISO 14630 more fully, including areas causing problems to the industry and offer recommendations on how conformity assessment can be managed. Additionally, results of our research could aid developers of the standard and support assessment of its adequacy by legislation,” says Haroon Atchia.
The table of contents is available on the QFI website at www.qualityfirstint.com.
The eBook may be requested from QFI by email to marija@qualityfirstint.com.
Price: $599 (plus VAT as applicable), 406 pages including covers, provided in PDF format.
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.
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Quality First International
Marija Capek
+44 (0)208 221 2361
www.qualityfirstint.com
Marija Capek
+44 (0)208 221 2361
www.qualityfirstint.com
Contact
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