The Medical Device Regulation (2017/745 EU, hereinafter MDR) imposes strict requirements on both the software development process and the software documentation. During a one-year period, Gerrit Lindenschot will support Maastro, on behalf of ICT Group, with the professionalisation of this project.
Under MDR colours
Erik Roelofs is a clinical physicist and PhD in Clinical Data Science. He has been working for Maastro for 18 years and, in addition to his clinical work, he recently took on the position of Chief Medical Information Officer (CMIO). Erik: “Maastro is an independent, international radiotherapy institute with about 350 employees, most of which are working in Patient Care. As Medical Technology Coordinator, I am responsible for making sure that the medical software that Maastro develop themselves is created and documented in accordance with article 5.5 of the MDR. We may work under MDR colours, but we do not certify our results because we do not intend to market them.”
Support from ICT Group
“Our developers are experts in the field of medical data and image processing. With documentation at such a high level, however, they do not have quite as much experience. That is why we outsourced this to ICT Group. Gerrit Lindenschot is very experienced in this area and has been counselling us, since the summer of 2021, on the necessary steps to take towards our own Quality Management System (QMS), in line with ISO-13485 for medical equipment. The project we are working on together is a prototype for which we intend to make a transition to our own clinic. The procedures and templates will have to be 100% accurate to do that.”
“Gerrit is a real senior QA/RA consultant. He trains us and guides the team through the professionalisation effort that we are making now. First, he carried out a benchmark and audit, then we started filling in the gaps. Proper establishment of therequirements goes a long way towards validating the product and releasing it for clinical use. We currently focus on establishing all procedures and supplying the templates. I want to be able to state, confidently, that we will have everything perfectly organised.”
Keeping a sharp eye on potential risks
“In late 2021, we took stock of our progress and decided that we could start with the implementation. Gerrit visits at least once a month and we talk weekly. That way, he keeps us sharp. Details are crucial in this process. Gerrit does not only know the potential risks of data-driven products, but the design principles and usability of the software as well. He thinks along and is very pragmatic in his approach. He helps us to maintain our grip on the software development and the supporting documentation.”
“Working with ICT Group is very pleasant. They place themselves completely in our position.”
The MDR determines that a healthcare organisation may purchase (legally the preferred option) or manufacture (not encouraged) medical equipment, or have it developed. Erik: “We have chosen to carry out this project ourselves. Radiotherapy is developing fast and we are at the forefront. Sometimes, there is not even a product available on the market so we have no other choice than to make it ourselves.”
MDR embedded in working processes
“What we are doing with ICT Group now, we want to apply to our other development programmes too. In that regard, this pilot has a much greater purpose: that of implementing a working method that will be the standard for all products and their corresponding documentation. The procedures to be followed will be described in great detail, so that we can easily reuse them later. In addition, the pilot also helps to assess the documentation of third-party software developers. It gains us an additional control mechanism for our suppliers' existing systems. And if we can outsource, we have more time to properly carry out the run-up. We know exactly what we need and what our capacity is, and we can support that with documents. Actually, we have MDR embedded in our working processes already.”
Healthcare holds no secrets for ICT Group
“Al in all, I would describe the cooperation with ICT Group as very pleasant. The healthcare domain holds no secrets for them. Gerrit is always thinking along, easily placing himself in our position, and is very good at estimating how much space we need! That is exactly what we need in the phase we are now going through as a relatively small organisation. Any healthcare organisation that operates in a similar way and wishes to keep their documentation under control could - maybe even should - follow this working method.”
About Maastro
Maastro is a nationally and internationally renowned radiotherapy centre that explicitly intends to make a connection between patient care, education, and effective scientific research.
