About
Conquering the complexities of today's regulatory environment is a challenge. We offer strategic regulatory consulting services designed to simplify the process and empower you to confidently launch your products. Our specialized knowledge of the US FDA, particularly for medical devices, SaMD, AI/ML and combination products, provides a distinct advantage. JemReg is led by a former FDA official that spent time at a large medical device manufacturer and then consulted for one of the world's largest law firms.
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Keywords
medical equipment manufacturing
design control procedures
regulatory gap analysis
step designation
medical device registration
quality system documentation
fda submissions
consulting
standards assessment
risk management
change control procedures
b2b
regulatory strategy
device registration and listing
healthcare
manufacturing
regulatory strategy development
investigational device exemptions (ides)
services
medical device compliance
technical documentation
510(k) submissions
udi compliance
regulatory timeline management
notified body submissions
other scientific and technical consulting services
government
pre-market approval
market clearance support
pmas
Company Information
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Employees 1
Location
Bethesda, Maryland, United States
