Webinar: Digitalize your quality management system – an efficient way to work and meet the requirements of MDR / IVDR.
What is required to digitalize and maintain quality information? It is without a doubt a change that requires specific competence and understanding of the scope of the project. Its impact on experts’ productivity can be tremendous.
Date: Friday, August 26, 2022
Time: 08:00 – 09:15 (CEST) with time for questions
Lectures: Andreas Gaarder & Tord Ringenhall
Webinar is arranged in collaboration with Swedish Medtech.
How do you get a digitalization of technical documentation and automatic generation of the Design history file?
Both MDR and IVDR places increased demands on your technical quality information regarding traceability. What do you do when you want to take the step and digitalize your documentation? And how to get the documentation for product development to fit in with your quality management system (QMS)?
During this webinar, we will go through what it takes to acquire the ability to manage your documentation digitally. We go through the fundamental principles what we found important when setting up a management system in a digital tool. To make these things complex is easy, but with the principles we are using as a guide it is not that hard to implement.
- Keep it simple, especially workflows. Complexity is easy to add but hard to remove.
- Connect processes in value streams
- Spend time on the information model
- Make procedures thin and guidelines fat!
- This simplifies audits!!!
- Don’t copy data around, link it, keep the single source of truth and maintain that!
- Make sure the traceability is maintained and supported by the system
- Differ between project and product
- Be prepared to change, work iteratively, involve both management and experts!
Taipuva is a consulting company and partner with Siemens Digital Industry Software and reseller of Polarion in the Nordic region. We implement structured requirements management and Systems Engineering methods in powerful tools to achieve more efficient projects and faster product development with automated traceability.
We implement a scalable digitalized solution for QMS processes that can be validated according to FDA’s 21 CFR Part 11 including electronic signing and meet the requirements of the new EU Medical Device and In Vitro Diaganostic (MDR and IVDR) directive requires.
What is a digital QMS?
A quality management system (QMS), implemented in an IT system that automatically manages all documentation of central product data and controls the way of working according to the company’s processes.
In product development, this means that a QMS supports the development of all specifications, linking, test results, etc. and automatically keeps track of all changes. Digital signatures and automatically generated reports simplify processes and project follow-up. A digital QMS can be validated as a tool to demonstrate regulatory compliance (adherence to MDR/IVDR) and is then the valid source for certification of the company’s products according to decided quality processes. Validation can take place, for example, according to the FDA’s 21 CFR Part 11.