Product: 3C Patch System
Industry: Medical Device
Company Size: 20 employees
Development Stage: Initial commercialization
Goal: Easier regulatory compliance and higher work efficiency
Our main concern was that it would take too long and require a lot of internal resources to digitize our QMS and DHF. However, we were up and running after about one month, which was much faster than expected.
Reapplix Video Testemonial
We agreed on a 3 step implementation process. This process offers a steadier transition but also requires more time. Compared to a “big bang” launch, which transitions all processes in one step, 3 step implementation is paced out and doesn’t put too much pressure on a busy organization.
We agreed on the following implementation phases:
The implementation of phase 1 took approximately 1 month. In the end, ReApplix transitioned their QMS to the following SimplerQMS modules:
- Document Control
- Design Control
- Equipment Management
- Supplier Management
- Customer Management
- Training Management
- Post-Market Surveillance
It can seem scary before you start and of course, there is some work getting from paper to an electronic system. However, when you start to see the benefits, you realize that it was the right decision. So just go for it!
Training and Support
The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive.
Successful Digital Audit
The Reapplix team mainly appreciated the fast integration of the software to their existing processes. Thanks to SimplerQMS, the team started to rely on notifications, which allowed them to better focus on their work and communicate requests more efficiently. When it was time for their first digital audit, Reapplix passed with flying colors. The auditor was impressed with the efficient search functions and the team’s ability to provide crucial documents in no time.
✓ Fast Implementation
✓ Ready-To-Use Procedures
✓ Reliable Customer Support
✓ Notifications and Reminders
The notified-body auditor was especially interested in our eQMS validation documentation, which is a requirement in ISO13485:2016. SimplerQMS had helped us with the validation and provided critical documents like the risk analysis, regulatory criticality assessment, validation plan, OQ & PQ, validation report and certificate. The auditor was very impressed with this work. We were able to find and show procedures, instructions, reports, meeting minutes etc. very fast by searching in the system