Presentation of Qualitiso Templates
Medical device manufacturers:
THE solution for your regulatory
and quality affairs!
- Build your Quality Management System
- Manage your products’ Technical Documentation
- Obtain CE marking for your medical devices
- Benefit from a tailored solution and keep pace with regulatory and standards developments
- templates, requirements covered, parameters, examples, comments and definitions
Master the Regulatory Landscape
Manufacturers
- Transition to the Medical Device Regulation
- Strengthen your QMS
- Keep up to date with new developments
- Address nonconformities
Start-ups
- Integrate medical device industry requirements
- Build a quality management system
- Implement the applicable standards
- Create the technical documentation for your devices
Consultants
- Work with a complete, up-to-date and consistent system
- Benefit from collective expertise
- Meet customer needs using online tools
- Keep pace with developments in the industry
Integrate Medical Device Requirements
F.A.Q
Yes, the templates can be used to successfully complete the CE marking of a medical device, obtain ISO 13485 certification and ensure device surveillance, provided that you invest the necessary effort in understanding and implementation!
1. The templates provide a response to every requirement of the referenced standards and regulations; this has been reviewed requirement by requirement
2. The templates are continuously improved based on user feedback and regulatory and standards developments.
Yes, the templates include notes and examples and are intended for beginners who do not have extensive experience in the industry.
A tutorial is available to guide you on the recommended order for implementing procedures and documents.
It will typically take between 6 and 18 months, depending on the resources you allocate, the risk class of your device and its complexity. In all cases, Qualitiso templates will help you accelerate the regulatory compliance process.
Yes, you can switch between languages directly from the interface.
Yes, the subscription price remains fixed until cancellation.
Price increases, applicable only to new subscriptions, are planned as new templates are created.
Two payment options are available:
1. by payment card, charged monthly; or
2. by bank transfer, paid every six months
Yes, but for optimal performance, we recommend using a Chromium-based browser (Chrome, Edge, Opera, Brave, etc.).
Yes 🙂 Since 2019, more than 300 companies and experts have successfully completed their projects using Qualitiso templates!