Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

The eSTAR 510k

The eSTAR 510k

The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) ...
Medical Device Reporting

Medical Device Reporting

Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical ...
Digital Health

Digital Health

Since the introduction of the term by Seth Frank back in 2000 [1], the idea of digital health has revolutionized ...
Unique Device Identifier

Unique Device Identifier

Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products ...
The 513(g) Process

The 513(g) Process

Classification of certain medical devices may be predisposed to ambiguities related to which classification type ...
Complaint Management

Complaint Management

Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined ...

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