Medical Device and In Vitro Diagnostic Regulation Transition Training

BSI has always worked hard to understand the current regulatory requirements in order for us to create training solutions that meet the needs of your organization. We work to ensure our training is robust, accurate and offers value to clients, whether we are training on existing standards, legislation or business improvement. We are one of the few certification bodies offering a diverse medical device training portfolio that consists of specialized training courses.

BSI is currently working on our in-depth interpretation of the MDR and IVDR, published in May 2017, and as such will not be offering training to the new regulations until we can offer you detailed and accurate transition courses.  As part of our Notified Body re-designation work, we are currently furthering our understanding and clarifying areas which we believe are not fully clear with the current information available.

As such, we are planning to launch our new transition training courses, incorporating the MDR/IVDR in early 2018 once we are clearer about the interpretation of some the new requirements and how they will affect your organization.

If you would like to express interest with us now, we will follow up with you once the courses are available.

For any enquiry, contact us at +6 03 2242 4211 or email info.malaysia@bsigroup.com