LONDON, February 16, 2017 /PRNewswire/ --
Strengthening regulatory infrastructure and improving competitive edge is at the forefront of the medical device industry. As UDI implementation continues in the North American regions, the global medical device industry is beginning to focus upon imminent European regulatory changes and the upcoming implementation for these geographies.
Regulatory bodies, device manufacturers, healthcare providers and numerous other stakeholders are gearing up for implementation in these regions which presents its own specific challenges and opportunities. With there already being at least one FDA 483 warning letter citing UDI non-compliance, it is detrimental to understand what manufacturers can do to make sure they're protected.
As the US races ahead with the UDI regime, the EU is still waiting for clarification on the expected requirements and what manufacturers need to do in order to comply. The release of the Medical Device Regulation (MDR) has provided some insight however; uncertainty still remains regarding the European UDI landscape.
Pharma IQ spoke to a selection of industry experts regarding the key hurdles the market should brace for and the majority agreed on data management with the EU UDI regime as a key area of focus. With this in mind, we are pleased to present the Data Complexities with the EU UDI Regime eBook to help you make methodical and evidence based approaches to avoid wasting resources on implementing the wrong plan.
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