Amazing news! We are now ISO13485 certified!
- Oct 9, 2021
- 1 min read
Updated: Oct 19, 2021
Excited to share that our Quality Management System (QMS) is now certified and fulfils the requirements of ISO 13485:2016.This means a lot to us as an organisation to be ISO certified. It not only adds to the credibility but also evaluates our QMS to be appropriate and effective while emphasizing the safety and efficacy of our medical device.
Our team worked for the entire 2.5 days with the auditor and left no stone unturned to bring this success to our doorstep. It is the result of great teamwork and we raise a special toast to our quality department. What a great work!
It’s a day of pride and great joy for all of us at Tada Medical AB today and we take this opportunity to thank everyone who has been directly or indirectly involved with our organisation.
Great news-achieving ISO 13485 certification is a significant milestone, especially in the medical device space where strict quality management systems are essential to ensure safety, compliance, and consistent product performance ; what stands out is how reaching this level requires coordinated effort across documentation, risk management, production processes, and ongoing improvement, which reflects a strong commitment to both regulatory standards and patient outcomes , and it also highlights how managing such complex, multi-step initiatives depends on aligning teams, resources, and timelines effectively, which is very similar to how organizations handle large-scale operations in other fields, something well reflected in project planning resources, where structured approaches help teams coordinate activities, allocate effort efficiently, and keep everything moving smoothly across multiple projects.
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