FDA & ISO Quality Systems

We Meet You and Your Company Where You are

Proven Systems for Seamless Business Management

  • 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.
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