QUALITY MANAGEMENT SERVICES
Medical Device Quality Management Services
Need help building your design history file?
Let's talk quality
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.
Medical Device Quality Systems
Archimedic’s quality management services help medical device teams define requirements, manage risk, and build Design History File (DHF) documentation aligned with regulatory expectations.
Client TestimonialsÂ
What Our Clients Are Saying About Their Experience With Archimedic