About
A health care partner who provides core solutions for your modern medical device and combination product development & commercialization to transform the lives of patients. We Support organizations from early development through post-market that help bring products to the market along with designing, establishing, and execution of complete Quality Management System (QMS). We offer services including end-to-end product launch support, establishing and implementing QMS, Gap Assessments, process development, and other Quality services.
Technologies
Outlook
Blue Host
Microsoft Office 365
Mobile Friendly
Google Font API
Nginx
reCAPTCHA
WordPress.org
Keywords
process & production controls
auditsinspection readiness
fda cfr 210211
quality management system
quality engineering
eu mdrmddivdrivdd
gap assessmentgap analysis
fda cfr 820
capa
process improvementleankaizen
traininglims
change control
iso 13485 qmsmdsap
combination products
supplier managementsupplier controls
medical device complaintsreportingvigilance
strategic thinking
iso1497124971 risk management
product launch support
product development
product validation
medical device
gap assessments
international regulatory standards
qualification activities
supplier management
validation protocols
medical devices
validation activities
medical device support
Company Information
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Employees 1
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Founded 2021
Location
575 Pinetown Rd, Fort Washington, Pennsylvania, United States, 19034-2709