Case Story
Transitioning to MDR
Background
Much of the documentation was in hard copy and there was a desire to merge all of the documentation into a common structure and style. Early on in the collaboration, we discussed establishing an online QMS platform for the day-to-day business of the company and maintaining technical file documentation.
“I choose to work with Laura because she is trustworthy. To begin with, I didn’t know the level of her professional knowledge, but she has proven her ability beyond a doubt.”
-Søren Badstue (Owner), Microwarm ApS
Product risk class
- Class I
Company size
- 1 employee
Task
- Transition from MDD to MDR
- Recommend and implement an online QMS platform
Goals
- Update and align the technical files with the MDR and UK MDR in a manner that takes into consideration:
- the products’ risk classification
- market history
- company size
- Find and implement an affordable Quality Management System, preferably on a scalable and transferable platform.
- Successfully pass an inspection by the Competent Authority with as few, preferably minor, deviations as possible.
Approach
Agreeing on the level of documentation and detail that was required to fulfill the regulations, we then updated and created the missing technical files to comply with the MDR. As all three products were Class I, they didn’t require a high level of documentation, but we wanted to ensure that it would be easy to understand and simple to keep updated.
The documentation requirements and QMS expenses needed to suit Microwarm’s products and resources. It was important that Søren was involved in decisions and took ownership of the process, so he could continue to maintain it.
“Laura uses the right approach with competent, well thought-out solutions and insights into the future that you can trust. You can entrust Laura with a task and give her relative freedom to solve it. You don’t have to watch over her shoulder all the time.”
-Søren Badstue (Owner), Microwarm ApS
Results
We identified a suitable QMS system which fitted Microwarm’s budget and implemented it. Søren was trained in the system and used it in cooperation with RAQA to maintain Microwarm’s documentation. The monthly price was very affordable, though the initial start-up costs were higher, due to the need for customized templates and configurations. However, the customizations were very useful and improved the daily use of the system.
All of the initial technical files were updated to the MDR and UK MDR and are now secured in the new QMS system.
While this process was underway, Søren developed a new product, and he used the QMS to manage all of the documentation.
The Competent Authority inspection was successful with very few non-conformances.
“I think it’s liberating to meet someone in this industry who does what Laura does, who is so honest. She is truly trustworthy, down-to-earth, and serious – a rare combination.”
-Søren Badstue (Owner), Microwarm ApS
Continued collaboration
RAQA continues to collaborate with Microwarm to maintain documentation. The QMS system helps us track all ongoing tasks, like PMS reports and risk management, with email reminders.
Besides document maintenance, RAQA assists and advises Microwarm with policy and procedural questions on an ad hoc basis. In addition, we continue to work together on issues such as questions from distributors, customer concerns, and entering new markets.
“It frees up some time for me, and it gives me a sense of security when I work with RAQA. I am sure that everything that is being done is in order.
I have already recommended RAQA to several people in the industry, and expect to do so again in the future.”
-Søren Badstue (Owner), Microwarm ApS
Get in Touch
We are here to help
Please send us a message and we will get back to you within 24 hours.