REQUIREMENTS DEFINITION
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.
RISK MANAGEMENT
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.
DESIGN CONTROL
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.
DOCUMENT CONTROL
Need document control for your DHF?
We will help you with complete document control and electronic approvals compliant with 21 CFR Part 11.
LET'S CONNECT
Looking for Quality Management Support?
Contact us through the form below. One of our team leaders will follow-up with you directly.