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
FMEA is an acronym that stands for Failure Mode Effect and Analysis which is a method for determining any and all possible points of failure in a design, process, or product. This is a combination of Failure Modes, which is a way in which something could potentially fail and result in defects, and an Effects Analysis which determines the consequences of those failures. During this, failures are prioritized by how serious their consequences are, their frequency, and how they are detected. Failures are eliminated based on their priority, starting with the higher priorities.
When issues occur that have the potential to impact product quality, Quality Assurance Reports (QAR) are generated to determine what happened, why it happened, and how to prevent it from happening again. An investigation is launched to determine this and what the potential impacts are.
Evolution is the process of how a species changes over time in response to their environment. Often termed “Survival of the Fittest”, the topic was studied most famously by Charles Darwin. While it is present across all species, one of the biggest impacts it can make is the change in a microorganism’s genome to resist antimicrobial products. These are used to treat and cure infections and sterilize surfaces among others. For this reason, antimicrobial resistance (AMR) has become a global concern.
The FDA has recently been putting a much greater emphasis on working smarter not harder when conducting clinical trials. Types of clinical trial designs called Complex Innovative Trial Designs (CIDs) which come in response to the rapidly changing drug development environment have recently been getting a lot of attention. These designs allow clinical trials to answer more questions in less time.
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