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.

Building a QMS for Your SaMD – Part II

Building a QMS for Your SaMD – Part II

In this second part of the webinar, we will review how to tackle changes that were made to the software post market, the verification and validation activities for your software, regulatory clearance of changes made to the software post market, and how to handle software recalls.
MDSAP – What it Means to Your Business

MDSAP – What it Means to Your Business

This webinar will explore the Medical Device Single Audit Program, or MDSAP. We will provide an overview of the program, including how the audit is conducted and what regulatory requirements are included. We will also explore what the MDSAP audit could mean for your business as far as marketing options in other countries, as well as compliance risks to medium and small size companies. Finally, we will review lessons learned with real-life (i.e. field) examples to help you understand and prepare for the audit.
Analyzing De Novo Devices

Analyzing De Novo Devices

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in ...

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