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European Union flags flying in front of a building
  • Insights
2023年7月6日

Does It Seem That European Regulations Now Prevail?

A look at the trend of how European legislation regarding medical devices and other products takes the form of...
European Union flag flying in the wind
  • Regulatory Update
2023年7月5日

MDCG Recommends Limits on Article 97 MDR Applications by EU Member States

The European Medical Device Coordination Group (MDCG) calls for limiting applications of Article 97 MDR for legacy...
EU flag waving in front of a building
  • Insights
2023年6月28日

Europe's Blue Guide, New Approach and New Legislative Framework

The roles of the Blue Guide and New Legislative Framework in European medical device regulatory systems
URRA HFRD 2023
  • Insights
2023年6月22日

Common Use-related Risk Analysis Pitfalls

A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process...
HFRD hearing aid 0623
  • Insights
2023年6月22日

Human Factors Considerations for Over-the-Counter Hearing Aid Manufacturers

Key human factors engineering and usability issues for makers of OTC hearing aid devices on the US market
HFRD self selection study 0623
  • Insights
2023年6月22日

Self-selection Study Tips Part 2: Conducting Self-selection Studies

Key considerations for conducting self-selection studies for medical devices
HFRD usability testing
  • Insights
2023年6月22日

What Does the Future Hold for Medical Device Usability Testing?

Medical device usability testing and the emergence of artificial intelligence
HFE PMS 0623
  • Insights
2023年6月21日

Webinar Debrief: Incorporating Human Factors into Post Market Surveillance

A look at key benefits of integrating HFE into medical device PMS processes
HFRD MW 0623
  • Insights
2023年6月21日

Wiklund’s Perspective: Human Factors Engineering in Consumer Product Design

A look at the benefits of human factors engineering in consumer product design
London Tower Bridge.
  • Regulatory Update
2023年6月19日

UK Regulators Plan New Medical Device Legislation for Summer 2025

The UK MHRA has extended timeframes for accepting CE Marked medical devices, and expects new legislation to roll out in...
Person taking notes on a clipboard while someone tests a medical device
  • Regulatory Update
2023年6月15日

Mexico NOM-241 and Equivalence with ISO 13485 for Medical Devices?

Mexican regulators have updated Good Manufacturing Practice (GMP) and quality management system requirements for medical...
Person doing an audit.
  • Regulatory Update
2023年6月9日

US FDA Looking Into Medical Device Registrants’ UDI, GUDID Compliance

US regulator targets possible discrepancies regarding Unique Device identification requirements
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