Leverage our expertise to solve complex regulatory challenges. We will design a regulatory and QMS strategy that takes your product to established and emerging markets worldwide.
We utilize years of hands-on experience to help our customers get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations.
Thousands of device companies choose Emergo as their independent in-country representative to maintain control of their device registrations.
We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.
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Expectations for Post-Market Surveillance (PMS) in the European MDR
What’s the status of your EU MDR Article 86 Periodic Safety Update Report (PSUR)? Class IIa legacy devices are approaching the deadline of their first PSUR, whereas Class III and IIb legacy devices should already have their first PSUR issued.
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