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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.
Download this infographic and discover 6 simple steps that can help you get certified to ISO 13485:2016 then maintain and optimize your certification.
LRQA’s Gap Analysis assessment examines and reports on your management systems’ readiness for transition. It focuses on how your management system has addressed, or plans to address, the changes introduced through the publication in ISO 13485:2016.
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
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. Click here to download now.
With the publication of the new IVDR and MDR regulations, regulatory affairs professionals and device manufacturers are 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.
Standards Council of Canada (SCC) has confirmed that Lloyd’s Register (LR) is now accredited to ISO 13485:2016 and ISO 13485:2016 under Canadian Medical Device Conformity Assessment System (CMDCAS) requirements, following a recent transition audit.
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.
This two day conference brings together executives who are responsible for product surveillance and reporting on a global scale to help ensure user feedback and complaints are handled appropriately and aligned with US and international regulatory requirements, streamlining and improving decision making, response times, and ultimately ensuring the safety and quality of medical products.
This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share. Find out what the IVDR & MDR Regulations mean to your organization - LRQA presents the top frequently asked questions.
The new EU IVDR will replace and repeal the existing IVD Directive 98/79/EC when it is published, currently expected during the second quarter of 2017. With the aim of tightening and strengthening the approval system for IVDs, the new regulation introduces a number of important changes
Susan Mecca, Senior Medical Technical Manager – Americas, LRQA will be a panelist during the opening keynote address, PERSPECTIVES ON THE EU MDR & DEVELOPING AN IMPLEMENTATION ROADMAP: