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About Roger Cepeda

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So far Roger Cepeda has created 3 blog entries.

Mobile Medical Apps & FDA Rules: What is the latest in 2017?

By |December 3rd, 2017|Regulatory Compliance|

In the world of mobile apps, things change quickly, and it stands to reason that, as mobile phone makers added [...]

EU Medical Device Industry: Regulatory and Privacy M&A Issues for a US Company

By |December 3rd, 2017|Regulatory Compliance|

For US healthcare companies considering an acquisition of a medical device or in vitro diagnostics company in the EU or [...]

FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?

By |September 13th, 2017|Regulatory Compliance|

On August 31, 2017, the FDA issued a final version of a guidance entitled, “Use of Real-World Evidence to Support [...]