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The publication of the MDR 2017/45 was a milestone in the Medical Devices revolution. On top of that, increasing world population, longer life expectancy and rising standards of living have also become catalysts for this innovation trend that will contribute improve general wellbeing and, hopefully, reduce healthcare costs.

How does this trend shift influence medical device professionals on their daily life?
As medical device expert players, we need to be able to keep up to this shifting trend. The speed to which guidelines and standards are released can be overwhelming. At the date of writing of this text, the European Commission’s Medical Device Coordination Group (MDCG) had 32 guidance documents in progress and the list is continuously updated, here.

How can one cope with such a speed of information coming in?
“Medical device” is an extremely expansive term that can encompass a wide range of items intended for medical use — from syringes and scalpels to prosthesis and pacemakers. Within this context, both, regulatory definitions, and classification are sometimes challenging.
Training plays a cornerstone role within this continuously evolving context. Professionals need to stay compliant to medical devices lifecycle regulations and to understand the challenges of meeting regulatory expectations and requirements.

Medical Device Training Program
LS Academy workshops address the different nuances of the Medical Devices environment. From different local regulations to European and International markets. These courses are designed for professionals involved in the life cycle of the Medical device industry who need to meet the challenges and requirements of local, European and international regulations and markets.