The manufacturing and testing processes of our instruments and devices are reliable, efficient, and subject to continuous monitoring.Įach production process is followed by safety testing performed with specially developed testing systems, and the results are individually documented: This means that before delivery, each product leaves its distinctive fingerprint. In close collaboration with accredited inspection offices, we perform detailed testing and obtain product certifications. For this reason, we exclusively use components with proven reliability and safety. Testing product quality is therefore an essential part of our quality assurance measures. KARL STORZ is particularly committed to the safety of our instruments and devices. In addition, the system meets the requirements of the European Medical Devices Directive 93/42/EEC Annex II and additional national regulations and legal requirements, such as the Canadian Medical Device Regulation, the Japanese Pharmaceutical Affairs Law, and the QSR of the US FDA. Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.KARL STORZ has put in place a certified quality management system in accordance with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016. Contact Customer Service for a quote or more information. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library - a personalized collection of FDAnews publications that is fully searchable. Identifying customer and other requirements. This easy-to-follow format shows the process at a glance, allowing you to track every stage, including: Establishing the project. Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. Download a complimentary checklist (PDF) This diagram outlines the steps for your ISO 13485:2016 implementation. Order your copy of ISO 13485:2016 - A Devicemaker’s Transition Guide today. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability. The report interprets the four key areas in the 2016 version - risk management, design control, supplier management and corrective and preventive action - and explains what kind of changes the new standard will require.īased on the insight of one of the world’s foremost ISO experts, this report is essential for any devicemaker that hopes to survive the coming transitions. This standard was developed by ISO Technical Committee (TC) 210, Quality Management and Corresponding General Aspects for. How recent revisions to ISO 9001 compare to the new 13485 ISO 13485:2016, Medical Devices Quality Management Systems Requirements for Regulatory Purposes, is a quality management systems standard for the medical devices industry that is derived from ISO 9001:2008.Some potential concerns related to ISO 13485:2016 and FDA’s QSR.The status of EN ISO 13485:2016 and issues related to the product directives.The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it.In this management report you will learn: It has a clause-by-clause, line-by-line, 46-page comparison of the old and new versions of 13485 that shows you exactly what and where the new requirements are ( click here for a sample). ISO 13485:2016 - A Devicemaker’s Transition Guide has done the work for you - saving you valuable time to make plans and put them in action. For example, the ISO 13485:2016 standard in PDF format is not available for free download you can access ISO 13485 in read-only (text) format for free or, if needed, purchase the ISO 13485 PDF. Do you know all the changes between ISO 13485:2016 and ISO 13485:2003?ĭo you have the time to sit down and figure out clause-by-clause and line-by-line the differences between the two? These free ISO standards are not available for free download in PDF, but they can be accessed in read-only text format from the official ISO website.
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