Aiming to ensure compliance with ISO 13485:2016?
Our Comprehensive Solutions
WHY CHOOSE US
We provide a comprehensive ISO 13485:2016 package to ensure your QMS is aligned with globally recognized standard ISO 13485:2016.
Secure your Legacy! Achieve QMS compliance and Sign-off a Conformity Assessment Agreement with your Notified Body before 26 September 2024!
As a medical device manufacturer, it is crucial to have a well-established quality management system (QMS) in place. If you lack a QMS, or if your current system is outdated or not fully aligned with ISO 13485:2016, Obelis is here to help you! The goal of our services is to ensure your QMS aligns with globally recognized standard. We provide a comprehensive ISO 13485:2016 package to facilitate a smooth set-up of your QMS, a vital aspect of medical device regulatory compliance.
Identify and address deficiencies in your current QMS with our thorough gap assessment services. Our experts evaluate your system against ISO 13485:2016 standard, pinpointing areas for improvement.
Training
Empower your team with training on QMS requirements. Our experts prepared online pre-recorded sessions, allowing your team to learn at their own pace and from the comfort of their home or office.
Implementation Meetings
Implementation meetings meant to discuss the advances of the QMS implementation and solving practical questions with the help of our experts.
Pre-Audit Services
Complete your preparations with our pre-audit service. Our experts conduct online preliminary audit to identify improvement points.
Obelis Group
Boulevard Brand Whitlock 30,Â
Brussels, 1200, Belgium
Tel: +32 (0)2 732 59 54
sales@obelis.net
© Obelis Group 2024
Templates
Streamline your QMS setup with our extensive library of documentation templates. These templates are designed to give an example and first starting point for your future QMS, making the setup process simpler and faster
Experience Matters!
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
Gap Assessment
Secure Your Compliance Today!
Full Name*
Secure Your Compliance Today!
