About
Business Consulting to Medical Device Manufacturers Assistance with ISO 13485 System Development and CE-Marking in accordance with 93/42/EEC FDA System Development and assistance with approvals Sterilisation Validation (Gamma, EtO & Steam) Plant Design for Medical Devices Clean Room Design and installation
Technologies
Microsoft Office 365
Apache
Mobile Friendly
CM4All
Keywords
fda approvals
sterilisation validation
clean air room design
cemarking
plant design
risk assessment
medical equipment and supplies manufacturing
iso 17025
medical device regulatory support
consulting
eto sterilization
medical device industry support
medical device standards consulting
construction directive
services
regulatory affairs support
clinical evaluation
authorized representative
product development
european regulatory compliance
medical device registration
medical device certification process
iso 18001
iso standards
medical industry consulting
medical device regulatory strategy
sterilization validation
medical industry standards
sterilization validation experts
iso 14644-1
Company Information
-
Employees 8
-
Founded 1989
Location
Regent Pl, Centurion, Gauteng, South Africa, 1692