About
Highly experienced Quality and Regulatory Consulting for Medical Device Industry. Specializing in small to medium sized businesses. Services include FDA & ISO 13485 compliance, quality system development, regulatory strategy, 510(k) submission, EU/CE compliance, US Agent Services, International Medical Device Submissions, Auditing, Supplier Qualification, Remediation and Training.
Technologies
Gmail
Google Apps
Google Cloud Hosting
Mobile Friendly
Wix
Varnish
Keywords
due diligence
eu ce compliance
supplier qualification
510 submissions
regulatory strategy
international submissions
fda & iso 13485
training
quality system development
auditing
medical equipment manufacturing
fda qsr
supplier audits
eu mdr training
regulatory expertise
global regulatory requirements
uncompromising expertise
regulatory pathway planning
global regulations
process validation
audit readiness
internal process audits
software validation
qms development
training and auditing
regulatory guidance
regulatory pathway optimization
regulatory pathway acceleration
fda 510(k)
mdsap
Company Information
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Employees 2
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Founded 2021
Location
Shelton, Connecticut, United States
