 | Renishaw Diagnostics Gains ISO 13485 Certification現在、このページはご希望の言語でご利用いただけません。 Google 翻訳を使用すると自動翻訳でページを表示できます。 弊社はこのサービスの提供に責任を持たず、翻訳結果を弊社でチェックすることはありません。 30 November 2011
ISO 13485 is a standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Allana Johstone, Renishaw Diagnostics' Head of Compliance said, “The BSI assessor was very impressed with our QMS System, our good practices, everyone she interacted with, and the general atmosphere she observed here at RDL. Our staff should be very proud of themselves for the outstanding contribution they have all made towards this achievement. It is unusual for a company as young as ours to have manufacturing included in the scope of the certification, so we are very pleased indeed.” Rupert Jones, General Manager, said, “We are delighted to have received this certification; it reflects a significant effort by all of our staff and reinforces our commitment to quality. The transition from an R&D company to a fully commercial organisation is a very challenging process and it is essential that we have the right people and systems in place to make this happen”. About Renishaw Diagnostics Ltd Renishaw Diagnostics has launched its first RenDx™ research-use-only (RUO) multiplex assay system and is working towards the obtaining of CE marking for the system as an in vitro medical device in Europe and clearance in the US. The Company is based in Glasgow, Scotland, and further information is available at www.renishawdiagnostics.com. DownloadsAll images and text copyright Renishaw Register for news updatesRegister for regular news updates from Renishaw お問い合わせ詳細 や価格についてのお問い合わせは、オンラインでお寄せ下さい。直接コンタクトをご希望の場合は、 現地レニショーオフィスまでご連絡ください。 |
Renishaw Diagnostics Ltd, developers of the RenDx™ Multiplex Assay System for infectious disease research and diagnosis, today announced that it has been certified to ISO 13485:2003 for the following scope: design, development, product manufacture and management of subcontracted manufacture of molecular diagnostic systems for infectious diseases.
