QUALITY MANAGEMENT SERVICES
Need help building your design history file?
Know your essential requirements?
We can help you characterize the drug-device interface requirements, user needs, and design inputs - the starting points for device development.
Need risk management expertise?
Our quality management team can help you systematically identify hazards, assess risk, and implement risk controls in compliance with ISO 14971 and 21 CFR Part 820.
Ready to implement design control?
We can help you develop the full Design History File (DHF) and Device Master Record (DMR) in compliance with ISO 13485.
Need document control for your DHF?
We will help you with complete document control and electronic approvals compliant with 21 CFR Part 11.
Looking for Quality Management Support?
Contact us through the form below. One of our team leaders will follow-up with you directly.