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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.
Penlon's core business is the design, development and manufacture of anaesthesia equipment and other complementary life support products.
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
With the medical regulatory landscape having undergone it’s most significant overhaul in years; comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organization.
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.
Download these free webinars to have an overview about Medical Device Regulation, In Vitro Device Regulation and ISO 13485:2016.
Advanced Oncotherapy PLC has successfully obtained ISO 13485:2016 certification for its LIGHT proton therapy system.
The decision marks an important milestone for the FDA and is another step towards the global harmonisation of regulatory requirements in the medical devices sector.
Lloyd’s Register (LR) has successfully achieved and has been formally granted an extension to scope against their existing ISO 13485:2016 global accreditation by the United Kingdom Accreditation Service (UKAS).
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.
This annual event hosts the global regulatory community and brings together regulatory professionals to share knowledge while addressing all things relevant to the dynamic medical device, pharmaceutical and biotech industries.
Download the on-demand presentation with Susan discussing how to implement and maintain ISO 13485:2016 in order to help manufacturers ensure a successful transition to the revised standard.
Connect with us in Seattle at the ASQ World Conference on Quality and Improvement.
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.