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MCRA

FDA EU MDR Clinical Evaluation Cybersecurity

MCRA is a US medical device, diagnostics and biologics CRO and consulting firm within IQVIA. Its FDA services span regulatory strategy, pre-submissions, 510(k), De Novo, IDE and PMA work, agency meetings and post-market support. MCRA also provides clinical research, quality assurance, reimbursement, cybersecurity, biocompatibility and global regulatory services, including European technical documentation and clinical evaluation support.

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Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

A

Are there equivalent classifications to FDA Class I and II viewers under EU MDR?

Anonymous · 1 comment
5 months ago
According to the FDA, there are two classifications for medical image viewers: Class I for non-diagnostic viewers (intended only for review) and Class II for diagnostic viewers. Is there a similar cla
Accepted 1 answer

Under the MDR, the situation is less clear than under FDA regulations. The MDD borderline manual suggests that a PACS or viewer only used for storing,

A

What is a MDR UDI? Unraveling the Importance of Unique Device Identification

Anonymous
about 2 years ago
What is a UDI in the context of the MDR and FDA?
Accepted 1 answer

A Unique Device Identifier (UDI) is a distinctive code assigned to medical devices (and their packaging) to provide them with a unique identity. Simil