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    ISO 13485:2016 Medical Device Regulation Nears

    Posted date : 2/20/2018

    We are at T-minus one year and counting before the EU’s new medical devices regulation (MDR) ISO 13485:2016 goes into effect. All certificates to the previous edition of the standard will expire February 28, 2019.

    The last major revision of this quality management system took place in 2003, so the magnitude of this update will significantly affect the industry.

    UL PURE Learning, in a longtime partnership with the FDA, developed a scalable training/mentoring approach to support global compliance initiatives like ISO 13485 to ensure operational and audit readiness.

    Whether your medical device enterprise is playing catch-up or working toward completing your 13485 transition, you will need top-tier expertise, supported by a robust QMS, to propel your employees across the finish line and begin the certification phase.

    On a strictly internal level, conducting gap assessments and the analyses needed to identify where more work is required, and plotting a course to eventual compliance, can be a daunting, time-draining project.

    The process to enable your organization to meet the new standard is a combination of employee awareness and training, programmatic review, redesign and updating operational procedures and documentation.

    Our world-class LMS expertise includes workforce qualification, skills development, career advancement and third-party certification.

    UL PURE Learning’s Alliance with the FDA

    The FDA is the global leader when it comes to regulating medical devices, pioneering regulations to ensure products coming to market are safe. ISO 13485 supports this approach, particularly as it relates to the design control cycle. 

    UL PURE Learning maintains a long-standing alliance with the FDA by providing extensive LMS training to its 36,000+ global, federal, state and local investigators.

    The new ISO 13485:2016 places an incredible emphasis on ‘risk-based thinking’ throughout the standard, a marked undertaking for medical device QA and compliance teams.

    ISO 13485:2016 requires medical device enterprises

    to demonstrate QA expertise to

    satisfy customer and applicable regulatory requirements.

    LMS for End-to-End Internal and External Supply Chain

    Medical device organizations may be involved in one or more stages of the life-cycle, including design, production, storage and distribution, installation, or servicing of a medical device and design and technical support.

    We have designed precise, easy-to-assimilate LMS modules which prepares seasoned ISO 13485: 2016 veterans as well as those who have a broader learning curve.

    UL PURE Learning’s proprietary training curriculum includes:

    • Training for management on their new responsibilities under the new standard
    • Risk management and design control activities during product development
    • Verification of effectiveness of CAPA’s
    • Demonstration that personnel are competent to perform their tasks as associated with the QMS

    ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

    ISO 13485 standards level the playing field

    between global powerhouses and small companies

    because everyone is “forced”

    to produce a safe, high-quality product.

    ComplianceWire® is our globally-respected learning technology adopted by the FDA.

    ISO 13485:2016 Training Delivery Flexibility

    Our QMS training can be delivered to your employees in a traditional live format from half day to two full days, depending on the staff’s depth of expertise in ISO 13485 compliance or delivered in an electronic version for self-guided eQMS learning.

    Why UL PURE Learning LMS and Advisory Services?

    • Our close alliance with U.S. Federal regulatory agencies, particularly the FDA, empowers us to share the very latest and most accurate compliance guidelines available.
    • For decades, UL has focused on protecting the end-to-end internal and external supply chain risk management.
    • UL’s team of in-house analysts and risk management professionals have garnered their expertise across a wide range of industries at the world’s most powerful regulatory agencies.

    Standards and regulations such as ISO 13485 empower medical device companies--of all sizes-- to compete on a level playing field.

    But the transition to a ‘risk-based thinking’ approach can be tricky for managers and their teams to implement.

    UL PURE Learning helps your organization to navigate this wave of changes to support compliance with the new edition, but also optimize processes for efficiency gains.

    As the leader in understanding global standards, UL has developed a scalable training/mentoring approach to support organizations, like yours, in their efforts to ensure operational and audit readiness.

    When companies partner with UL PURE Learning, they gain access to world-class LMS, life sciences, compliance and quality professionals who maintain advanced expertise in technology solutions, including critical migrations like 13485. To learn more, call +1-609-627-5300.