CEO of the London-based medical device regulatory consultancy Quality First International - has written a critical examination of Commission Implementing Regulation No 920/2013 on audits and assessments by Notified Bodies.
London, 8 February 2018
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written a critical examination of Commission Implementing Regulation (EU) No 920/2013 on audits and assessments by Notified Bodies. The article, published as part of the series “The Compliance Papers”, considers the adequacy of the general approach, as well as the elements and possible areas that may still require reinforcement to ensure fulfilment of public trust.
“Enquiries to select Notified Bodies has revealed differing expectations, and consequently varying extents, of unannounced audits of critical subcontractors and crucial suppliers. Partly this is due to a lack of understanding of the Commission’s recommendations, which restrict the right of access to sub-contracted manufacture”, states H Atchia who is also a Medical Devices Lead Assessor and Expert Witness.
The article may be requested from QFI, email marija@qualityfirstint.com, reference: Atchia, H: Examination of Commission Implementing Regulation (EU) No 920/2013 on audits and assessments by Notified Bodies, The Compliance Papers 5 (2), 1–19, 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.
For further information please contact: Marija Capek, PR/Press
Tel: +44 (0)208 221 2361, Email: marija@qualityfirstint.com, Website: www.qualityfirstint.com
