Tuttlingen – Most medical technology companies are aware that regulatory affairs departments need relief. Also that digitalization is the method of choice. So much for the theory. In order to get things started, a workshop on January 18th in Tuttlingen will begin implementation - the example of electronic technical documentation is also a door opener for a new joint project by MedicalMountains GmbH.
When it comes to creating or updating technical documentation, the hard search sometimes begins on hard drives and in filing cabinets. According to required information and documents. According to the current revision status. For the right place within the structure. For possible defects. In short: after the overview. Finding all the information and transferring it via copy-paste “takes an average of 40 percent of the entire time,” is the experience of Michael Kania, managing director of the solution provider meddevo from Bad Hersfeld. Giving this time back to the regulatory affairs experts and giving them more breathing room is the goal of the digital support - and thus of the workshop with Michael Kania in Tuttlingen. The day starts with laying a common ground. “You first have to know what options there are,” Michael Kania is convinced that digitalization is more than just using software. It means gradually leading people with their challenges and questions into a new process way of thinking. In the second half of the workshop, the participants then work independently with an electronic TD tool – “qualification by doing,” so to speak.
The workshop is open to small, medium and large companies. The information on basics, strategies, pitfalls and implementation is conveyed independently of the platform, although the training on the software ties in with the new joint project between MedicalMountains GmbH and meddevo: Medical technology companies with up to 50 employees can apply for the joint project “Digitization of Regulatory Affairs”. “This can and should enable smaller companies with fewer resources to get started,” explains MedicalMountains managing director Julia Steckeler. The community is valuable in several ways. First of all, because the financial contribution is lower than if it were commissioned individually. In addition, “no one has to go it alone with the software; instead, they remain in dialogue with us, meddevo and other parties involved.” For example, questions could be solved together and best practices exchanged.
The joint project is designed to last three years. Although the contract can be terminated annually, Julia Steckeler sees “convincing added value” in keeping it for the entire duration. Michael Kania also advocates taking your time. “The transition doesn’t have to be hard, and we don’t advise it to be,” he says. At the beginning, only documents could be transferred into the system. “It takes little effort and offers many advantages in a short time,” before further processes and content management followed. Predefined templates also make the switch easier, but can be adapted depending on the circumstances. “Every company is different and can adapt and expand database models, build their own templates or change folder structures,” reminds Michael Kania – without having to worry about missing out on the next audit. “The software is pre-validated and if there are any changes, we will look at them and make an update.” Further details will be provided at an online session on January 24th.
- Workshop “Digitization of Regulatory Affairs – electronic technical documentation”
Thursday, January 18, 2024, 9:00 a.m. – 4:30 p.m., IFC Tuttlingen - Info session & kick-off for the joint project “Digitization of Regulatory Affairs”
for medical technology companies with up to 50 employees;
Wednesday, January 24, 2024, 10:00 a.m. – 11:00 a.m., online
