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    • Wiklund’s perspective: Smart products--and ideally intuitive as well!

      Applying human factors engineering and usability principles to support more intuitive usability of smart medical...

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      Emergo by UL's HFR&D team reports on the 2022 HFES Health Care Symposium

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May 17, 2022

Wiklund’s perspective: Smart products--and ideally intuitive as well!

Applying human factors engineering and usability principles to support more intuitive usability of smart medical devices

Read More
May 17, 2022

Key Takeaways from the 2022 HFES International Symposium on Human Factors and Ergonomics in Health Care

Emergo by UL's HFR&D team reports on the 2022 HFES Health Care Symposium
Read More
May 12, 2022

Singapore issues new guidance for software as a medical device

Singapore’s medical device regulator has issued new guidance on SaMDs.
Read More
May 11, 2022

India’s DCGI adds more medical device testing laboratories

India now has 21 registered medical testing laboratories.
Read More
May 10, 2022

EU market update: Compliance for medical device makers in the EU and Turkey just got easier

Turkish regulators align medical device and IVD requirements with European MDR, IVDR
Read More
May 5, 2022

US FDA Outlook: What MedTech can expect in 2022 and beyond

What medical device manufacturers can expect from the FDA in 2022.
Read More
May 4, 2022

What Human Resources could learn from Quality and Compliance in life sciences organizations

Training tied to quality and compliance operational imperatives may be more effective for life science companies
Read More
May 2, 2022

EU IVDR Update: 3EC International becomes seventh Notified Body designated under EU IVDR

3EC International joins roster of Notified Bodies designated to IVDR.
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Apr 27, 2022

Mexico Market Update: COFEPRIS releases new requirements for online medical device submissions

Mexico's COFEPRIS issues several medical device digital registration and submission updates
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Apr 27, 2022

Medical device versus medical product: European MDR guidelines on borderline products

European MDCG provides new guidance on MDR versus MPD compliance for borderline products
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Apr 26, 2022

Australia Market Update: TGA publishes latest medical device application processing times

Australia’s TGA has published its latest medical device application processing times.
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Apr 22, 2022

US FDA's latest medical device cybersecurity guidance: Key differences from previous versions

Emergo by UL examines changes and clarifications in the latest FDA guidance on medical device cybersecurity
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Apr 22, 2022

IVDR Watch: European regulators update SSCP rules, high-priority implementation actions and technical documentation guidelines

Medical device manufacturers doing business in Europe should take note of a number of updates...
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Apr 20, 2022

Wiklund's Perspective: Innovation in the context of user interface design

Innovative UI design supports safe and effective product use, minimizing risks of use error.
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Apr 12, 2022

Brazilian regulators update Good Manufacturing Practices for medical devices and IVDs

Revisions to Brazilian Good Manufacturing Practice (BGMP) quality management system requirements for medical device and IVD manufacturers
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Apr 12, 2022

Australia Market Update: TGA expectations for transition to 2021 Advertising Code and updated guidance on reclassification of AIMDs

The Australian Therapeutic Goods Administration (TGA) has issued several notices recently affecting medical device manufacturers...
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