Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
Full Service
Full Circle Consulting
When
Product Development
Regulatory Submissions
Post Market Compliance
Manufacturing and Distribution
Why
Regulatory Strategy
Quality System Development
Quality System Implementation
EMMA OnDemand
Featured Services
COVID-19
EU MDR and IVDR
MDSAP
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Full Circle Consulting Resources
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.
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.
One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are ...
Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every ...
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