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
There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.
Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.
A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a product or quality problem in the pharmaceutical and medical device industry. The fishbone diagram is additionally known as the Ishikawa diagram, created by Kaoru Ishikawa in the 1940s.
A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue with a product or process. According to the FDA “The purpose of the corrective and preventive action subsystem is to collect information,...
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