Published On: 23. June 2020

Savings in labor and time when processing IEC 60601-1

MST-Instrumente GmbH is an ambitious company for the development, production, assembly and distribution of human and veterinary medical devices. Since 1992, the company, run by brothers Jürgen and Volker Müller, has been developing medical electrical devices such as high-quality plaster and autopsy saws and horse tooth rasps.

Challenge – changeover to IEC 60601-1 Edition 3

As an SME, MST-Instrumente GmbH’s main challenge was the conversion of IEC 60601-1 to the third edition. Due to the adaptation of the standard, many additional tests on the devices became necessary, which meant immense additional work and time expenditure with the previous procedure using simple document processing programs.

The importance of risk analysis increased enormously, so the company from Dürbheim near Tuttlingen was looking for an efficient solution that would also reduce the potential for errors in the area of risk assessment and evaluation.

Opting for the market leader

The Risk Manager has been used in the company since 2005 to create risk management files. As it was known that the solution had extension modules, such as for medical electrical devices, the brothers decided to evaluate the full version of Risk Manager first. All relevant requirements and standards should therefore be covered in one system in a clear and time-saving manner. During the test phase, the company’s employees were able to quickly find their way around the system. By linking the data and creating a structured structure, they were quickly convinced that they had found the most efficient approach. A subsequent search for comparable solutions confirmed the considerations, so that MST-Instrumente GmbH opted for the full version with extensions for usability and requirements engineering as well as for checking the basic requirements in addition to covering IEC 60601-1.

Cost savings achieved

After a quick and problem-free implementation of the solution, we were able to start working on the documentation straight away. In addition to the efficiency achieved, the user guidance is self-explanatory, so that “learning by doing” is possible. Due to the checklist processing procedure within the framework of IEC 60601-1, only the topics that are really necessary for the plaster saws and other medical devices need to be checked. At the same time, all standards and directives are always up to date and their content is complete.
“You can find what you’re looking for very quickly and “only” have to concentrate on the content of the documents. Now I can sleep easy knowing that I have complete documentation,” concludes Jürgen Müller.

Support even after the purchase

But even after the purchase, MST-Instrumente GmbH will not be forgotten by BAYOONET AG. Customers have the option of using a ticket system and always receive fast and competent help from a personal contact. A software update contract also guarantees that all changes to the integrated standards will be made available to the customer during the transition period. For Mr. Müller, Risk Manager is therefore “the first choice for anyone who is looking for an integrated solution for technical documentation with few personnel.

Konformitätsbericht Risk Manager

Creation of the conformity report for medical electrical devices according to IEC EN 60601-1 - Risk Manager simplifies the process with an intelligent questionnaire linked to the more than 1,500 tests of the standard

Your efficient and compliant approach to Technical Documentation

Your validated solution concerning documentation processes of Medical Devices and In Vitro Diagnostics – On the way from risk management, regulatory and product requirements to Usability and Clinical Evaluation: Digitize interlinked processes with BAYOOSOFT Risk Manager and reduce documentation efforts sustainably while minimizing redundant data at the same time.

Is your company looking for a strong partner for management software solutions?

Contact us now and we will present our products to you without obligation. 

Sounds exciting? Why not share this article with your network?