“What is a Quality System, why do I need it, and how do I get one?”

Unlike many other 510(k) consultants, Vision28 is a full service Quality and Regulatory organization dedicated to helping guide you through all of the regulatory and quality requirements imposed on medical device manufacturers by FDA. We can help you answer these questions as well!

What is a Quality System?

The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (cGMP’s). An FDA compliant quality system is comprised of procedures, work instructions, and forms that generate records demonstrating the design, manufacture and distribution of your product meets the requirements of federal regulation 21 CFR part 820.

Why do I need it?

A Quality system helps ensure that your products consistently meet applicable requirements and specifications. cGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing cGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820. In 1990, FDA undertook the start of the revision of the cGMP regulation to add the design controls authorized by the Safe Medical Devices Act. After an extensive effort, the part 820 was revised and went into effect June 1, 1997.

How do I get one?

Vision28 has developed a complete quality system including procedures, work instructions and forms that may be used to generate the records you need to demonstrate you meet the requirements of cGMP. This system, QMSL (Lean Quality Management System) is designed to meet all requirements for Device cGMP, and comes at an affordable cost. Included are:

  • Management Responsibility
  • Quality Audit
  • Personnel & Training
  • Design Controls
  • Purchasing Controls
  • Identification
  • Production & Process Controls
  • Inspection, Measuring & Test Equipment
  • Process Validation
  • Acceptance Activities
  • Non-Conforming Product
  • Corrective & Preventive Action
  • Labeling & Packaging Control
  • Handling, Storage, Distribution & Installation
  • Quality Records
  • Servicing
  • Statistical Techniques

Whether you need to add to your current system or if you need a complete ground up system QMSL provides you a LEAN and cost effective solution ideal for start-up and growth phase companies. Call us to lean how we can help you establish your quality system:

(541) 604-9654