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UL Pure Learning Blog

Industry knowledge and expertise in compliance and regulatory solutions.

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Six Tips to Reap the Rewards of Employee Micro Learning

It is true that the methodology of learning is changing. With a new generation of millennial learners and a growing array of technology mediums, the traditional use of the LMS is evolving. Note I said evolving--not expiring. Learning activities are increasingly moving toward the point of need and being delivered outside of the traditional LMS model. However, this can only be done for specific use cases and does not apply to all critical learning happenings in an organization. This is particularly true in highly regulated industries such as medical device, pharmaceutical and healthcare.

The LMS is Still the Regulatory Workhorse of the Life Science Industry

It is true that the methodology of learning is changing. With a new generation of millennial learners and a growing array of technology mediums, the traditional use of the LMS is evolving. Note I said evolving--not expiring. Learning activities are increasingly moving toward the point of need and being delivered outside of the traditional LMS model. However, this can only be done for specific use cases and does not apply to all critical learning happenings in an organization. This is particularly true in highly regulated industries such as medical device, pharmaceutical and healthcare.

ISO 13485:2016 Medical Device Regulation Nears

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.

New Medical Device Regulations Introduced in EU

As the European Union implements new Medical Device Regulations, it may pose some obstacles for manufacturers. As the changes are implemented, medical device manufacturing organizations need to keep a close eye on how the regulations are being rolled out and what modifications will force changes, more education and/or a different approach to the product.

MDR Priorities Discussed at MedCon

At this year’s MedCon, held at Xavier University in Cincinnati, OH from May 3 to 5, the good vibe from US FDA’s efforts to accelerate product approvals was washed away by the burden that EU MDR will have on medical device and IVD companies. MDR will officially go live at the end of May, and experts at the event provided three steps that companies should do now to prepare.

Case Study - MDSAP Audit Experience

UL leverages Compliance Insight experts for many of our medical device courses. Compliance Insight recently participated in a Medical Device Single Audit Program (MDSAP) program, which consisted of two auditors along with three other observers. The observers consisted of one individual from FDA, one from Health Canada, and another from the Notified Body.

Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) was developed by International Medical Device Regulators Forum to provide an annual audit program with a global approach to auditing and monitoring the manufacture of Medical Devices that would be accepted by multiple International Regulatory Agencies.

Cyber Security Issues Confronted by Medical Device Industry

In January, the FDA released two separate draft guidances that provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.

New Draft Guidances on Medical Product Communications

In January, the FDA released two separate draft guidances that provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.

Cybersecurity in Medical Devices

Major breaches of servers holding secretary of state emails or personal credit card information gain major headlines. This is especially true with the presidential election with a tremendous focus on emails that were made public after they were stolen from an unsecure email server.