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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.
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 new IVD Regulation (IVDR) will require sampling of technical files for review by a Notified Body for devices classified as B or C under the regulation.
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.
While waiting for the publication of the new regulation, which is expected in Q1 2017, medical device and IVD manufacturers are still subject to random unannounced factory inspections by Notified Bodies at least once every three years.
Under the existing IVDD, approximately 80% of IVD manufacturers are self-certified and do not require Notified Body involvement. The new IVDR comes with new classification rules which will in the near future require about 80% of IVD manufacturers to require some form of Notified Body involvement, a four-fold increment from before.
This guide has been developed to share the experiences of our clients that have already successfully transitioned to ISO 9001:2015 and ISO 14001:2015.
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.
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.
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.
LRQA's Medical Devices experts recently spoke at The Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence. This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share.