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With our experts at your side, you are well-prepared for any audit or inspection by the relevant authorities. We have already successfully supported dozens of medical laboratories and guided them to compliance – without any complaints in the authority audit.
We provide you with a clear understanding of what the law and the authorities require of you. By implementing the requirements using your own devices as examples, you will immediately know what needs to be done and how, enabling you to plan your efforts reliably.
We can help you quickly comply with the IVDR and ISO 15189. This way, you can impress with fast results, and your institution with legally compliant devices that can continue to be used legally.
Our experienced experts are not only familiar with all requirements and suitable methods but also kind. With us, you get field-tested concepts and quick and reliable answers to your questions.
Our more than 100 experts cover all relevant topics, from risk management to performance evaluation. We monitor all regulations and standards for you and help you achieve full compliance in all areas.
You benefit not only from the expertise we pass on to you but also from templates that have proven themselves countless times in audits and reviews. That puts you on the safe side and saves you time and money.
With the enforcement of the EU IVDR (Regulation (EU) 2017/746), health institutions such as medical laboratories must now also comply with comprehensive and complex legal requirements for their in-house IVD medical devices (IH-IVD), often also referred to as laboratory developed tests (LDT). These include the requirements of ISO 15189 for the quality management system.
Many institutions wonder why they are suddenly faced with such an extensive and complex additional burden, especially since their tests have been in reliable use for a long time. Conflicting information adds to the uncertainty about what specific steps need to be taken now. Where do you start?
Added to this is an acute lack of resources: too many other tasks, combined with limited budgets and specialist staff, lead to fears of overwork. And as if that were not enough, many institutions are under pressure for not having made sufficient preparations for the upcoming changes.
Failure to meet the requirements can have serious consequences: In addition to problems with insurance and possible fines, the responsible authorities can, in the worst case, remove previously used in-house IVD medical devices from the market and prohibit further use.
We have made it our task to provide clarity and show health institutions how to meet these challenges. As a partner on their side, we support them in effectively and efficiently complying with the regulations.
Contact us now to plan your first steps towards IVDR compliance.
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With our support, you can ensure the quality of your analytical and clinical performance studies and their results.
We help you to pass the approval, audits, and technical reviews quickly and safely with legally compliant performance evaluation files.
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