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In this complimentary webinar, our human factors engineering (HFE) experts outline the latest regulatory update from the U.S. FDA, published on Dec. 9, 2022.
In this complimentary webinar, we review the resources you’ll require and the steps you should take to complete your path to market in Japan.
Join the HFE experts at Emergo by UL as they discuss both tips to follow and pitfalls to avoid when writing user interface requirements.
Join the HFE experts at Emergo by UL as they discuss regulator expectations for electronic instructions for use (eIFUs).
The new JIS T62366-1:2022 standard comes with updated requirements on usability engineering for medical devices.
Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the next steps for Switzerland.
Review recently released and expected guidance documents from the US FDA, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.
This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation.
In this complimentary webinar, we examine resources developed by the European Commission.
In this webinar, we provide information on considerations for designing and classifying SaMD in the United States and European Union.
Watch the HFE experts at Emergo by UL as they discuss the importance of conducting URRAs effectively.
Watch as HFE experts discuss the application of HF engineering to medical devices intended for at-home use.
In this complimentary webinar, we examine current medical device registration requirements in Brazil, recent regulatory changes and current ANVISA registration requirements.
General principles of GDPR and actions manufacturers can take to gain or maintain compliance.
Secure data management to meet HIPAA, PHI, and requirements of Covered Entities or Business Associates.
Secure data management to meet HIPAA, GDPR requirements and achieve regulatory compliance.
Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.
All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA).
Before manufacturers of certain medical devices can sell within India, they need to be in compliance with India’s medical device regulations.
All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.