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Industry knowledge and expertise in compliance and regulatory solutions.

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

Google the phrase ‘is the LMS dead?’ and you’ll be hit with almost 2,000,000 search results. 

ISO 13485:2016 Medical Device Regulation Nears

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.

3D Printing of Medical Devices

The case for 3D printing within the medical device field is strong. The act of 3D printing, for those who might not know, is the process of creating a physical object from a three-dimensional digital model through the layering of the material until an object is created.