Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
So, you don’t think you are manufacturing medical devices used in the home setting. Think again. The line between the acute care and home care setting is fading.
Did you know that products now need to comply with 60601-1-11 if they have been designed for and intended for hospital use but could be used in the home setting and/or they are sold into a European Nursing Home?
Intertek's newest white paper entitled, “Intertek: Guide to Medical Electrical Equipment Used in the Home Healthcare Environment and Standard IEC 60601-1-11,” will arm you with valuable information about the basic safety and essential performance of medical electrical equipment used in home settings. It will walk you through the standard clause by clause and provide valuable insight into how to achieve conformance.
Complete the form below to download the White Paper.