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

Vision28 professionals have experience developing and defending quality systems in companies whose sizes range from Fortune 100 world-wide companies to start-ups trying to get their first product approved by 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! 

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 who don’t want to spend significant dollars for a medical device quality system, and who 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

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