As all medical electrical equipment must comply with the relevant standards to support safety and quality; many in the industry have used EN 60601 to meet compliance requirements for medical device safety, electromagnetic compatibility, usability, and risk management.
BSI provides medical electrical device testing and certification services for assessing conformance. We can help to certify that your products meet all regional requirements, such as CE and UKCA. This allows market access across Europe and provides your device access to more than 50 countries with a single certificate, through the IECEE CB Scheme.