Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.
The first thing your lab needs is a strategy for documenting workflows, whether you’ve got 50 or 250 in-house tests. This webinar will outline several possible approaches.
The next step is formulating the intended purpose for your in-house tests. From here this webinar will also cover documenting qualification as a medical device and risk classification under IVDR.
This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.
Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.
Lernen Sie unsere Herstellerpartner kennen und erfahren Sie mehr über die Best-Practice-Workflows, die wir gemeinsam mit diesen auf unserer Plattform entwickeln.
GSPRs sind anspruchsvoll, und genau darin liegt die Schönheit etablierter Standards: Sie sind state-of-the-art und können als solche zuverlässig die GSPRs erfüllen. Finden Sie heraus, was Ihr Labor tun muss und wie Sie es am besten angehen.
Um die Anforderungen zu erfüllen und die Sicherheit und Zuverlässigkeit für Patienten zu gewährleisten, müssen Labore über ein solides Risikomanagementverfahren verfügen. Dieses Webinar bietet Orientierung.
We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.
We’ll take you through various aspects of product excellence required by IVDR, from instructions for use to labeling, SOPs and documenting the design and manufacturing of your in-house tests and components.
Perhaps the most daunting aspect of the IVDR for labs are the new requirements for clinical use surveillance. We’ll explain what active vigilance throughout the life cycle of your in-house tests means for your lab.
Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including what is coming in the final phase of implementation in 2028.
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Name of the controller:
Jakov-Lind-Strasse 15/Floor 2/Top 3
Contact Details of the data protection officer
or via post
DPO c/o Platomics GmbH
Supervisory Authority for the compliance with data protection regulations in Austria:
Telefon: +43 1 52 152-0
Below is an overview of the data we can collect:
Below are the main methods we use to collect data:
We can use your data for the following purposes:
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We may also disclose your information in the following circumstances:
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Please note that we keep the collected data for as long as it is necessary to provide our services, to comply with our legal and contractual obligations to you, to resolve disputes and to enforce our agreements.
We can correct, supplement or delete incorrect or incomplete data at our own discretion at any time.
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Regardless of the measures and efforts taken by us and our hosting provider, we cannot and will not guarantee the absolute protection and security of the data that you upload, publish or otherwise pass on to us or others.
For this reason, we would like to ask you to set secure passwords and, if possible, not to provide us or others with confidential information, the disclosure of which, in your opinion, could cause you significant or lasting damage. Since e-mail and instant messaging are not considered secure forms of communication, we also ask you not to pass on any confidential information via any of these communication channels.
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We reserve the right to request proof of age at any time so that we can verify that minors are using our services. In the event that we become aware that a minor is using our services, we can prohibit these users from accessing our services and block them, and we can delete all of the data we have stored about this user. If you have reason to believe that a minor has disclosed data to us, please contact us as explained below.
As an EU resident, you can:
Please note, however, that these rights are not unlimited and may be subject to our own legitimate interests and regulatory requirements. If you have general questions about the personal information we collect and how we use it, please contact us as detailed below.
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If you are based in the EEA, your personal data will only be transferred to locations outside the EEA if we are convinced that there is an adequate or comparable level of protection of personal data. We will take appropriate steps to ensure that we have adequate contractual arrangements with our third parties to ensure that appropriate security measures are in place so that the risk of unlawful use, alteration, deletion, loss or theft of your personal data is minimized and that these third parties act in accordance with applicable law at all times.