What are the recent regulatory changes in biocompatibility?
Recent changes include updated ISO standards and stricter testing requirements for medical devices.
How do these changes affect the approval process for new medical devices?
These changes may lengthen the approval process as manufacturers must comply with new testing protocols.
Are there specific industries that will be more impacted by these changes?
Yes, industries like orthopedics and cardiovascular devices are likely to face more stringent regulations.
What steps should companies take to adapt to these new regulations?
Companies should review their compliance strategies, update testing protocols, and train staff on new requirements.
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