LRQA’s Medical Devices industry expert discussed ‘Annex SL and its impact on ISO 13485 and the Medical Device Industry’ at the 2014 RAPS: The Regulatory Convergence annual conference.
Organised by Regulatory Affairs Professionals Society (RAPS), this is the world’s largest annual global gathering for the healthcare product regulatory profession, attracting around 2,000 industry experts and professionals and 100 exhibitors to discuss important developments in the medicine, healthcare technology and regulations.
The conference provided opportunities for delegates not only to build knowledge and competencies, but also to catch up with trends, share ideas, discuss what’s on the horizon and network with peers who understand their challenges.
Annex SL and impact on ISO 13485
Regulatory and management systems around the world no longer exist in isolation. Healthcare is global so regulators and regulatory professionals must think and work globally too.
The publication of Annex SL will have a significant impact upon the structure of, and the forthcoming revision to ISO 13485. Annex SL (formally Guide 83) is the new high level management system format that helps streamline the creation of new standards, providing a consistent and compatible approach, making implementation of multiple standards within an origination easier. LRQA’s presentation at the 2014 RAPS conference included the latest information on ISO/DIS 13485:2014 which identifies the proposed changes to device technical files, design records and the lifecycle of all medical devices among other key elements.
Want to know more?
If you want to keep abreast of the changes to help ensure a smooth transition to ISO 13485:2015 and/or ISO 9001:2015, download your free copy of the presentation slides LRQA delivered at 2014 RAPS conference. In support of World Quality Day (WQD), we have also produced a free guide for you to download which discusses all things quality including a white paper on ISO/DIS 9001:2014.
World Quality Day Organisations across the world have been celebrating World Quality Day and the contribution that quality management and people like you have made to organisational and national development since 1990. The theme of this year’s events is ‘Building a quality world together’.
How can LRQA Help?
As a leading notified body for MDD and IVD Directives, and certification and training body for ISO management systems certification, LRQA are always looking at ways to provide the right support, help and information at a time that suits you.
Check out our current range of services that can help you prepare for the transition or achieve the new standards:
- Gap analysis - a pre assessment visit to identify weaknesses in your management system
- Training - a range of In-Company and public courses to meet your learning needs
- Pathway - a self-assessment tool to verify your progression with implementing a MS
- LRQAstandards.com - a web-store for you to purchase standards, books and related material
- eXpedite - a fast-track service on Medical Device Technical and Design Dossier reviews
- Revisions - latest information on the changes and transition arrangements to standards