IVDReady webinar series
COMING SOON 26/05/2024 4:07 am
Jun 20, 2023
IVDReady by May 2024 with Platomics

Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.

6. Juli 2023
1. Let’s talk strategy

Das erste, was Ihr Labor braucht, ist eine Strategie für die Dokumentation von Workflows, egal ob Sie 50 oder 250 interne Tests haben. In diesem Webinar werden mehrere mögliche Ansätze vorgestellt.

Jul 25, 2023
2. Give it a purpose

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.

Aug 29, 2023
3. Perplexity is the beginning of knowledge

This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.

Oct 12, 2023
4. Gate Opening: Introducing the Workflow Studio

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.

Jan 30, 2024
5. GSPRs are challenging, standards are beautiful

GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs. Find out what your lab needs to do and how best to get it done. 

Mar 5, 2024
6. An ounce of validation

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.

2024
7. The real risk is not managing risk

Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients. This webinar will provide orientation. 

2024
8. Product excellence: Everything, everywhere, all at once

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.

2024
9. Vigilance: The shield, sword and light

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.

2024
10. IVDReady at last

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.

Imprint

Platomics GmbH, Jakov-Lind-Strasse 15/3, 1020 Wien, AT

Emails:

info@platomics.com

platox-notifications@platomics.com

Telephone number: +43 660 7154 402

Firmenbuchnummer/registration number: FN 415581z

Firmenbuchgericht/commercial registry court: Handelsgericht Wien

Unternehmensgegenstand/business purpose: Dienstleistungen in der automatischen Datenverarbeitung und Informationstechnik, insbesondere Design und Entwicklung, Herstellung, Betrieb und Vertrieb von Software für regulatorische Dienstleistungen zur Unterstützung der Einhaltung der IVDR für Hersteller von Medizinprodukten, Gesundheitseinrichtungen und Aufsichtsbehörden (27340875); Herstellung von Medizinprodukten und Handel mit sowie Vermietung von Medizinprodukten (27340875). / Services in automatic data processing and information technology, in particular the design and development, production, operation and distribution of software for regulatory services to support compliance with the IVDR for manufacturers of medical devices, healthcare institutions and regulatory authorities (27340875); manufacture of medical devices and trade in and rental of medical devices (27340875).

UID: ATU68813304

Mitgliedschaften/Memberships: Wirtschaftskammer, Verband der Diagnostica-Industrie e.V, AUSTROMED

Anwendbare Rechtsvorschriften/ applicable legal provisions: Gewerbeordnung (s. https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10007517)

Zuständige Aufsichtsbehörde/ competent supervisory authority: Magistrat der Stadt Wien; BASG

Geschäftsführer/Managing director: DI Dr. Albert Kriegner

Gesellschafter/shareholders: Lansdowne Investment Company Cyprus Limited; Tansanit Stiftung; Siigno.gmbh; GreyBird Venture Associates, LLC; Nikolaus von Bomhard; Topas Stiftung.

Ausrichtung der Website/website orientation: Auf dieser Website wird das Unternehmen mit seinen Tätigkeitsschwerpunkten und Leistungen präsentiert sowie Informationen zur IVD-Branche dargestellt. / This website presents the company and its main areas of activity and services as well as information on the IVD sector.

Die Verbraucher haben die Möglichkeit, Beschwerden bei der Online-Streitbeilegungsplattform der EU einzureichen: http://ec.europa.eu/odr. Sie können Ihre Beschwerden auch an die oben genannte E-Mail-Adresse richten. // Consumers have the option of submitting complaints to the EU’s online dispute resolution platform: http://ec.europa.eu/odr. You can also address any complaints to the e-mail address given above.

 

 

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