What are the key regulations in medical technology?
An example of an AI chatbot conversation about regulations in medical technology.
What are the key regulations in medical technology?
Key regulations include the FDA guidelines in the U.S., CE marking in Europe, and ISO standards globally.
How do these regulations impact innovation in the field?
Regulations ensure safety and efficacy, but they can also slow down the approval process for new technologies.
Can you give examples of recent regulatory changes?
Recent changes include the FDA's Digital Health Innovation Action Plan and updates to the EU Medical Device Regulation.
What challenges do companies face in complying with these regulations?
Companies often struggle with the complexity of regulations, high costs of compliance, and keeping up with changes.
Are there any resources for staying updated on these regulations?
Yes, resources include the FDA website, industry newsletters, and professional organizations like AdvaMed.
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