PDF-based Quality Management System that has been reviewed in detail by FDA inspectors, FDA Washington DC staff, and by multiple EU Notified Bodies, assuring your business is audit-ready with a proven quality system.
A paper-based system is economical and does not require you to learn new software or have your business interrupted by software bugs and crashes.
Vision28 has helped customers attain EU MDR, ISO 13485:2016, and MDSAP certification, and has helped customers succeed with 21 CFR 820 FDA audits.
Vision28 professionals have experience developing and defending quality systems in companies ranging in size from worldwide Fortune 100 companies to start-ups trying to get their first products approved by the FDA and certified by Notified Bodies.
Direct, hands-on responsibility for quality systems.
We customize the Quality Management System for your business, integrating your existing work instructions and procedures into the Quality Management System.
We can create Design History Files, Device History Records, Device Master Records, perform validations, and perform a risk analysis.
Strong support staff means we can have you up and running in two to four weeks.
We can provide training and ongoing support, and ensure scalability as your company grows.
Need help with FDA & ISO Quality Systems?
Schedule a Free Consultation
Your journey to a successful regulatory submission and your LEAN Quality System begins here
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.