No need to sweat when file inspections are pending – with our experts at your side, you are well prepared for any audit and review and avoid unnecessary deviations.
With us, creating your software file is a breeze. We are actual practitioners with years of experience in regulatory affairs and as software architects and developers. We support you in efficiently designing and implementing your development process, thereby accelerating the approval of your devices.
Because we have already brought well over 100 software devices to market, we know exactly what needs to be done. We can provide a targeted strategy with a precise estimate of the costs and effort involved right from the start. That gives you structure and full transparency over the exact course of the project.
Our experienced experts know all the regulations and suitable methods like the back of their hands. With us, you only get proven concepts that work in practice.
Our more than 100 experts also covers all related topics, such as risk and quality management, (clinical) performance studies, and IT security. They can provide you with comprehensive support in implementing the requirements.
You benefit from templates that have proven themselves countless times in audits and reviews. This keeps you on the safe side while also saving you time and money – even with further device approvals.
The regulation of software medical devices and IVD software poses challenges for many manufacturers. These range from qualification to compliance with regulatory requirements for technical documentation, including the practical implementation of QM specifications and the
design of the development process.
The requirements of the AI Act, which came into force in 2024, must also be considered for manufacturers that use artificial intelligence or machine learning methods.
With our help, you can confidently overcome these challenges and avoid market launch delays due to unnecessary rework.
Save yourself research and tedious work – request our free AI Act Starter Kit. It provides an overview of the new regulation and its demanding, imminent tasks.
Learn more
Our experts help you to qualify your software and classify it as a medical or IVD medical device according to the regulatory requirements of the respective market.
For devices that use machine learning procedures, we help establish and implement processes for data collection and evaluation and ensure documentation of model development. Our experts are also happy to help define interpretability requirements and select methods for explainable AI.
We support you in optimizing and streamlining your software development process to maximize efficiency.
Our team can help you create a complete and lean IEC 62304- and FDA-compliant (AI) software file or take on the creation of individual reports and documents, such as:
We are also happy to review your existing documentation for conformity with the relevant requirements and provide targeted suggestions for improvement.
Our experts can also help you to process deviation reports you may have received.
Contact us if you want our support in developing and approving your software-based medical device.
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Our experts help you achieve a lean and ISO 13485-compliant quality management system without bureaucratic frustration.
Our expert team will help you quickly and safely pass the approval, audits, and reviews with a legally compliant cybersecurity file.
Our IT security team detects security vulnerabilities in your software devices early and fixes them so you can launch them quickly and safely.
We help medical device software manufacturers pass the approval, audits, and reviews quickly and safely with legally compliant clinical evaluations.
We help IVD software manufacturers pass the approval, audits, and technical reviews quickly and safely with legally compliant performance evaluation files.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops are the key.
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