Another major challenge of the new MDR is the handling of the Post-Market Surveillance (PMS) system. This PMS system will impact all economic operators, not only the manufacturers. Let us look into the details.
In our previous post, we spoke about the importance of the appointment of a Person Responsible for Regulatory Compliance (PRRC) as one of the key requirements in the new MDR (EU) 2017/745. Today, we focus on one of the next hottest topic – the new technical documentation.
As you put into practice risk management procedures, you would have a system that allows you to identify hazards, estimate and evaluate risks, as well as develop, implement and monitor the effectiveness of risk control measures you have in place.
The new MDR (EU) 2017/745 brings about changes that will create new jobs as well! In this article, we will look into the new requirement of appointing a Person Responsible for Regulatory Compliance (PRRC).
Starting 1 July 2019, companies applying for a new or renewal of Korea Good Manufacturing Practice (KGMP) certification will be subject to a few new requirements. Still, this does not have to be a cause for worry.
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