QMS – Design Control, CAPA, NCMR, Complaints, Training

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.

What we have found over the years is that overly complex systems hamper the basic mission of the company and may expose the company to compliance risk! That’s why we offer business Quality Management Systems that are designed to streamline your business and reduce the amount of time and money spent on quality management.

Vision28 QMSL is a complete 21 CFR 820 and ISO 13485:2016 compliant quality system. Paper-based, it is ideal for start-ups and growth-phase companies that don’t want to spend significant dollars for a medical device quality system and that want to get a system up and running in weeks instead of months. QMSL Standard Operating Procedures include:

  • 0001-SOP Quality Manual
  • 0002-SOP Design Control
  • 0003-SOP Document Control
  • 0004-SOP Purchasing Controls
  • 0005-SOP Production and Process Control
  • 0006-SOP Acceptance Activities
  • 0007-SOP Nonconformance NCMR
  • 0008-SOP Corrective and Preventive Action CAPA
  • 0009-SOP Device Master Record
  • 0010-SOP Device History Record R
  • 0011-SOP Quality Records Rev A
  • 0012-SOP Complaint Handling MDRs
  • 0013-SOP Risk Management
  • 0014-SOP Statistical Techniques
  • 0015-SOP Personnel and Training
  • 0016-SOP Internal Audits
  • 0017-SOP Management Review
  • 0018-SOP Handling Storage and Distribution
  • 0020-SOP Installation

Contact us at your earliest convenience to learn about how our business Quality Management Systems can benefit you and your business. We have helped businesses of all sizes streamline their operations and save time and money in the long run. Let us show you what Vision28 can do for you.

Give us a call and learn how Vision28’s QMSL can help you!