When it comes to clinical evidence requirements under the EU’s Medical Device Regulation (MDR), the biggest challenge for manufacturers, irrespective of device risk class, is determining the amount of data needed to generate sufficient clinical evidence.
The challenges in obtaining the quantity of evidence required, particularly for high-risk devices, have led to certain products being taken off the market. In turn, this has led to medical...
Key Takeaways From Clinical Evidence Study
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Customer complaints are the main source of reactive data for all companies when it comes to sourcing clinical evidence
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50% of respondents...
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