Training & Support
Customized Technical Training and Consulting Services are also available in:
Sterilization, Quality Assurance, Regulatory Affairs, & Risk Management
FDA Regulations for the Medical Device, Pharmaceutical and Combo Products
Quality System Regulations (GMP’s)
ISO 13485 & the European Medical Device Directives
Canadian Medical Device Regulation
Customer Complaint Handling & Investigation Systems
Vigilance Systems
Internal and Supplier Audit Programs
Regulatory Compliance Programs including Regulatory Responses
Contamination Control Programs including Environmental Corrective Actions
Continuous Improvement Programs
Quality Systems Development and Pre-assessments
ISO 11135, 11132, 11137
ISO 14971
Literature Reviews under ISO guidelines |
