In order to market and sell their products worldwide, Medical Device manufacturers have to comply with an ever increasing range of regulatory requirements. Conforming to all of these regulations can be both expensive and time consuming so it is vitally important that this activity is properly planned and executed.
At the ETL SEMKO Division of Intertek UK, we provide a complete package of services to help Medical Device manufacturers to comply not only with these requirements but also to ensure that their products will be safe, reliable and durable.
Advantages of using Intertek
- A full range of Notified Body services to ensure compliance with all relevant EU directives.
- Global Market Access using the CB Scheme, our own Certification Marks for Europe and the US, and a range of worldwide agreements, including FDA 510K.
- Combined EMC and Safety testing to provide a co-ordinated solution. For example, to avoid making EMC changes that would subsequently fail electrical safety.
- Support services for Software Evaluation and "Accelerated Life Testing" to assess reliability and durability.
- Design support services that offer consultancy throughout the product development cycle, to avoid those last minute problems.
FREE Webinar: Medical Devices Directive (MDD)
April 2nd: The New MDD for Medical Devices Webinar
Click here to find out more & register
Site Map
Site Map
