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The Poly Implant Prothese (PIP) Breast Implant Scandal is one of the most significant patient protection failures in the history of clinical research.
As traumatic as it was for the patients involved, it has also been credited in part for triggering significant regulatory changes in the European Union—including the new EU MDR requirements.
Here's a look back at what happened and how the regulatory landscape in Europe has changed as a result.
In an article written by Jamie Hartford and published in MDDI, indicates that new EU medical regulations are expected to be finalized this year or next. In an earlier blog, we wrote on the pending regulations and the impact it might have on the medical device industry.
Topics: European Union, PIP Scandal, Regulations, MD+DI