UL experts Mark Leimbeck and Laura Elan will be speaking at The MedTech Intelligence 13485:2016 Conference: Aligning the standard to ISO 9001 and 14971, the QSR and other regulations on July 28-29, 2016 Washington, DC.
Conference Website: http://www.cvent.com/d/7fqgc4
The final version of ISO 13485:2016 was recently published, requiring significant changes in human resources, management responsibility, and many aspects of the quality management system, including a risk-based approach to process development, greater focus on supplier controls and software validation, enhanced planning activities, new documentation requirements, and retroactive remediation for legacy products and systems, among many others.
In addition to the changes required by the new version of 13485, companies will struggle with the overlapping but different requirements of 9001, 14971, the Quality System Regulation, the impending update to the Medical Device Directive, and other standards, regulations, and guidances. What are the best approaches to establishing procedures that comply most effectively with all relevant requirements with minimal duplication of effort?
- New EU Standards and Regulations
- 13485:2016 Overview
- ISO 9001:2015
- Risk Management
- Design Controls and CAPA
- Software Validation
- Supplier Evaluation and Oversight
- Complying with Multiple Standards and Regulations
- Human Resources and Management Responsibility
- Medical Device Files
- Complaint Handling and Postmarket Surveillance
- Notified Body Audits under the New Standards and Regulation
• Patrick Caines, Director, Quality & Global Post Market Surveillance, Baxter Healthcare.
• Tamas Borsai, Division Manager, Medical Health Systems, Customer Service & Quality TÜV SÜD
• Lara Elan, North America Customer Solutions Manager UL LLC
• Roberta Goode, President & CEO, Goode Compliance International (GCI)
• Mark Leimbeck, Program Manager, Medical Regulatory Advisory Services UL LLC
• Walt Murray, President & CEO, ARC Experts
Presented as a hybrid event, plan to attend this conference in person, in Washington DC or from your desktop.
Register before July 15th and save! Early bird and team discounts are offered.
MedTech Intelligence's conference CEUs can be applied to your Regulatory Affairs Certification.
Presented by MedTechIntelligence, a digital trade journal, https://www.MedTechIntelligence.com