Presentation of Qualitiso Templates
Medical device manufacturers:
The solution for your
regulatory and quality affairs!
- Build your Quality System
- Manage the Technical Documentation of your products
- Achieve the CE marking of your medical devices
- Follow the news and developments in the industry
- Take advantage of a tailored offering and stay in step with regulatory and standards developments
- templates, requirements covered, parameters, examples, commentary and definitions
Master the regulatory environment
Manufacturers
- Transitioning to the MD regulation
- Consolidating your QMS
- Staying current with new developments
- Respond to non-conformities
Start-ups
- Integrating MD industry requirements
- Build a quality system
- Implement applicable standards
- Create technical documentation for your devices
Consultants
- Work with a comprehensive, up-to-date, and consistent system
- Take advantage of collegial expertise
- Meet customer needs with online tools
- Staying in step with industry developments
Integrate medical device requirements
F.A.Q
Yes, the templates allow you to complete the CE-marking of a medical device, obtain ISO 13485 certification, and ensure device monitoring, as long as you put in the effort to understand and implement!
The templates brings a response to each requirement of the claimed repositories, this has been reviewed requirement by requirement
2. The templates are continuously improved, as user feedback and regulatory and normative changes are made.
Yes, notes and examples accompany the templates, they are intended for beginners who do not have much experience in the sector.
A tutorial is available, advising you on the order of implementation of the procedures and documents.
It will typically take 6 to 18 months, depending on the resources you devote to it, the level of risk in your device and its complexity. In any case, Qualitiso templates will help you speed up the regulatory conformity process.
Yes, you can switch from one language to another directly from the interface.
Yes, the price of a subscription remains fixed until terminated.
Rate increases, applicable only to new subscriptions, are planned as new templates are created.
Two payment options are available:
1. by credit card, debited monthly, or
2. by wire transfer, made semi-annually
Yes, but for best performance, it is recommended to use a Chromium-based browser (Chrome, Edge, Opera, Brave…).
Yes 🙂 since 2019 are more than 180 companies and experts who have been able to complete their projects thanks to Qualitiso templates!