Lloyd's Register: LRQA USA [ Change ]
+1 866 971 5772
Improving Performance, Reducing Risk
Medical quality management
We have a variety of resources about ISO 13485:2016 including: datasheets, interviews, podcasts, webinars, case studies and independent research to help you to get the best from your quality management systems.
The revised standard for medical devices, ISO 13485:2016 and the European Standard version, EN ISO 13485:2016, were published earlier this year allowing a three-year transition period that will apply to all existing certificates.
This interview is the first of a two-part series where Susan Mecca, LRQA Technical Manager, Medical Devices, shares her thoughts on the new ISO 13485:2016 medical quality management system (QMS) standard, and how it impacts manufacturers.
Overview of ISO 13485:2016 (Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes)
In this 20 minute webcast, Susan Mecca, Senior Technical Manager, Medical Devices - LRQA Americas, will provide practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016, particularly those around Risk Management and the Interconnection with other Regulatory Requirements to the corresponding Medical Device Directives (MDD) and In Vitro Diagnostic Medical Devices (IVDD).
Medical Device Single Audit Program (MDSAP) Frequently Asked Questions - Certified once, recognized globally
The classification rules shown in this download will help manufacturers determine which classification applies to their medical device.
LRQA’s guide to the MDR Conformity Assessment Procedures will help you understand the different routes to compliance, and which route applies to your medical device.
These classification rules will help manufacturers determine which classification applies to their in vitro diagnostic device (IVD). Download now!
Then, based on the classification of the IVD, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.
With the new IVDR expected to be published in Q2 2017, regulatory affairs professionals and device manufacturers are now seeking clarification on how to implement the new requirements within their organizations.
Download these free webinars to have an overview about Medical Device Regulation, In Vitro Device Regulation and ISO 13485:2016.
Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organizations involved in medical device manufacturing.
The Netherlands presidency of the Council and representatives of the European Parliament (EP) reached a political agreement on the new Medical Devices Regulations and In Vitro Diagnostic Devices Regulations (IVDR) yesterday. When will the new regulations be published, and what does this mean for medical device manufacturers and Notified Bodies?
ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) was published on 1 March 2016. In this second interview, John Howlett, LRQA Medical Devices Technical Manager, shares his opinions on the revised standard and its potential impacts on medical device manufacturers.
LRQA, the world’s leading provider of professional assurance services, will be attending the upcoming annual Life Sciences College (LSC), an innovative and widely-attended global conference series launched by U.S. law firm Sidley Austin LLP in 2012.
LRQA is proud to sponsor RAPS EU MDR/IVDR Virtual Program, these sessions will deliver expert insights into the changes and impact of the Medical Device Regulation and In Vitro Diagnostics Regulation.
Connect with us in Charlotte at the ASQ World Conference on Quality and Improvement. Visit us at stand #509 and discuss completing your transition to the revised standards.
The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC and In Vitro Diagnostic Device (IVD) Directive 98/79/EC. Both Regulations are currently in their final stage of development and are expected to be published towards the end of Q1 2017.
Join LRQA in Schaumburg, IL at Food Safety Consortium, where many well respected industry experts converge to network and collaborate with other food safety professionals and peers. The consortium will also provide an extensive overview and evaluation of the Food Safety and Modernization Act (FSMA) final rules.