QMSL – Vision28 LEAN Quality System
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! If you write something in a procedure, FDA will expect you to follow your procedure and any deviation will be seen as a violation.
We have developed QMSL, a LEAN Quality System suitable for companies in their start-up (pre-product release), growth (product introduction and growth) or expansion (acquisition or multiple products) phase. We offer 21 CFR 820 compliant systems and 21 CFR 820 / ISO 13485 compliant systems.
Give us a call today and find out how we can help you focus on your business by knocking down one of the major entry barriers to the medical device market: Quality System Implementation.
We also offer cloud-based document control, eQMSL, ideal for growth or expansion phase companies. Call for a demonstration!
Pre-Existing Quality Systems
If you already have a quality system, let us perform a gap analysis to assure you have covered all of the necessary regulations, and let’s see if we can eliminate potential compliance risk exposure.
Let us help you by removing the redundant or non-regulatory aspects of your system that may be preventing you from fully focusing on your primary business objectives, while minimizing your cost of quality and risk of non-compliance.