The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively. There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design including 'usability,' 'human factors engineering' (HFE)” and 'ergonomics.' HFE has been added to regulatory requirements to: reduce medical device use error create more operator friendly and intuitive devices reduce the training costs for both manufacturers and end-users. Visit our main page for clear and educational resources and guidance, including: Standards for Human Factors Engineering FDA Requirements Articles & Published book resources Podcasts and recorded webinars Visit the page here Contact the European team to learn more
Expert assessment of products to determine suitability, quality, reliability and regulatory/standards compliance.
Quality and Safety Assurance for Apparel, Textiles, Footwear and Leather
Safety and quality validation services to protect our children
Tailored, production-smart solutions for textile, apparel and footwear companies throughout the production cycle: find the right fit for the modern demands of consumers and regulations.
The PURE™ Platform – the industry’s first integrated Environment, Health, Safety, (EHS) and Sustainability software solution designed to drive business performance.
Quality assurance, compliance and global market access services for the footwear industry