Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
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Modernizing your QMS to keep up with the Modern Age of Requirements
1. TRUE QUALITY SUMMIT SERIES
MODERNIZING YOUR QMS TO KEEP UP WITH
THE MODERN AGE OF REQUIREMENTS
Radhika Pandya
Product Marketing Specialist
Ben Bancroft
Medical Device Guru
3. A lot of professionals
start out like this…
And that is ok!
4. AGENDA
1. Problems with Present Solutions
2. Why is it so hard?
3. Need for Modernization
4. Modernizing Quality & Your QMS
5. Leading with Quality
5. MOST START WITH PAPER (but looks can be deceiving)
Expectations vs. Reality
○ Resources
○ Cost
○ Downstream effects
1 out of 3 Medtech companies are still using paper even though it
correlates with lower performance.
6. Reality of Paper
Expensive down the road, need to hire
additional employees to keep up with manual
work.
Prone to mistakes, clunky processes, not flexible
Lots of resources - Time, $, employees
The downstream effects of not having a
compliant and traceable eQMS can directly
impacts the lives of your patients.
Expectations of Paper
Low Starting Cost
We can make it compliant and it is flexible to
my needs.
Low resources needed
Quick way to get started
DOWNFALLS OF PAPER
9. NEED FOR MODERNIZATION
Lack of Insights
Visibility and traceability are lost.
There’s no easy way to identify gaps
and downstream impacts
Lack of Capabilities
Manage product lifecycle while
navigating ever-changing regulatory
requirements. With the wrong tool, this
can get messy.
Work Smarter, Not Harder
Scale efficiently
10. WHAT MAKES A QMS MODERN?
Recipe for a Modern QMS → eQMS
1. Cloud-based ecosystem
2. Validated
3. Automated
4. Built-in Compliance
11. WHAT MAKES AN eQMS POWERFUL?
1. Onboarding and training programs
2. Traceability and connectivity across the eQMS
3. Templates
4. Efficient
5. User friendly, easy to use
6. Support team
12. WHAT MAKES A QMS SUCCESSFUL?
Leading with Quality
87% of Market Leaders use
purpose-built solutions to
manage their QMS
13. MAKE THE SWITCH TO BECOME A
MARKET-LEADING ORGANIZATION
GET YOUR PERSONALIZED DEMO
TODAY →