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.

Jul 6, 2023
1. Let’s talk strategy

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.  

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. 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. 

2024
6. 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
7. 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
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.

Privacy Policy

Thank you very much for your interest in PlatoX®. At Platomics, we attach great importance to the protection of your personal data. In this privacy statement we explain how we obtain and use your personal data. We handle your data with great responsibility and in accordance with EU data protection law. 

Controller 

The controller for all processing of your personal data described below is 

Platomics GmbH
Friedmanngasse 38-40/1/17
1160 Vienna, Austria
info@platomics.com 

Contact Details of the data protection officer: 

E-Mail privacy@platomics.com 

or via post 

DPO c/o Platomics GmbH
Friedmanngasse 38-40/1/17
1160 Wien 

Using our public website www.platomics.com 

Webserver & Logfiles 

In a nutshell: When opening or interacting with our platform, your browser exchanges information with our web-servers. This data is automatically stored in so-called logfiles. Additionally, we will store essential cookies on your client and process personal data on our webservers. 

Purpose: Our webservers process your data in order to deliver the requested website to your browser. We save all requests in logfiles to guarantee the security and functioning of our website. 

Categories of data: Essential cookies according to our cookie policy, Technical data (Timestamp, IP address, HTTP header fields, Referrer URL, Device IDs, Device-Fingerprints, Browser-Fingerprints) 

Legal basis: Providing the requested online content and guaranteeing the security and functioning of our website are our legitimate interests. We thus process your data in accordance with Art 6 (1) (f ) GDPR. 

Storage period: We delete our logfiles automatically after 14 days. In case we require the logfiles for a longer time period (e.g., in case of a security or safety incident), the storage period may be extended accordingly. 

Recipients / Categories of recipients: Processors (host service provider) 

Analytical Statistics 

In a nutshell: With your consent we will use an external analytics provider (Google Analytics) to gain information about your interaction with our public website. Please refer to the privacy policy of Google Analytics for additional information. The usage of this analytical service is optional.  

Data transfer This data processing activity includes data transfer to recipients which are certified under the EU-U.S. Data Privacy Framework 

Purpose: We want to understand how you use our website and gain insights about our visitors so we can improve its design and functionality. 

Categories of data: Technical data (Timestamp, IP address, HTTP header fields, Referrer URL, Device IDs, Device-Fingerprints, Browser-Fingerprints); Additional cookies according to our cookie policy will be stored on your device 

Legal basis: After giving consent we process your data in accordance with Art 6 (1) (a) GDPR “Consent”. 

Storage period: We store your data until you withdraw your consent. 

Recipients: Google Ireland Limited (located at Gordon House, Barrow Street, Dublin 4, Ireland) and Google LLC (located at 1600 Amphitheatre Parkway, Mountain View, California 94043, USA) 

External services (Youtube, Google Maps) 

In a nutshell: With your consent we will integrate external services like Youtube and Google Maps, embedded into our website. Please refer to the privacy policy of Google Maps and Youtube for additional information. The usage of these external services is optional. 

Data transfer This data processing activity includes data transfer to recipients which are certified under the EU-U.S. Data Privacy Framework 

Purpose: We want to provide additional services like integration of videos, maps and similar services on our website 

Categories of data: Technical data (Timestamp, IP address, HTTP header fields, Referrer URL, Device IDs, Device-Fingerprints, Browser-Fingerprints); Additional cookies according to our cookie policy will be stored on your device 

Legal basis: After giving consent we process your data in accordance with Art 6 (1) (a) GDPR “Consent”. 

Storage period: We store your data until you withdraw your consent. 

Recipients: Google Ireland Limited (located at Gordon House, Barrow Street, Dublin 4, Ireland) and Google LLC (located at 1600 Amphitheatre Parkway, Mountain View, California 94043, USA) 

Wizards and Questionnaires 

In a nutshell: We offer wizards and questionnaires to provide additional information and functionality to you. The usage of these external services is optional. 

Purpose: We want to provide additional services. 

Categories of data: Technical data (Timestamp, IP address, HTTP header fields, Referrer URL, Device IDs, Device-Fingerprints, Browser-Fingerprints); 

Legal basis: We process your data for fulfilling a contract in accordance with Art 6 (1) (b) GDPR 

Storage period: We usually store your data for a maximum of 12 months 

Recipients: TYPEFORM SL, Calle de Pallars 108 (Aticco), 08018 – Barcelona (Spain) 

Business activities 

Customer request 

In a nutshell: If you have any questions about our company, our Platform, our service(s), suggestions or complaints, you can contact us via e-mail, phone or other contact details published on our website, on our platform, in our manuals or provided elsewhere. 

Purpose: We process your data in order to answer your request. 

Categories of data: Contact details (name, address, e-mail address, telephone number, company name, responsibility within company); details of your request 

Legal basis: Answering your request might be necessary for the performance of a contract, to take steps prior to entering into a contract or for the purpose of our legitimate interest to ensure consumer satisfaction or fulfil legal obligations. We thus process your data in accordance with Art 6 (1) (b) GDPR or Art 6 (1) (f) GDPR. 

Storage period: In general we store your data 7 years. In case additional regulations apply (e.g. medical device regulations) we might be obliged to extend the storage period according to the corresponding law. 

Recipients: Processors 

Newsletter 

In a nutshell: We regularly provide interested customers with information on updates on our products, services, events, webinars in our newsletter. We may ask for feedback, market insights, improvements and your satisfaction with our services. 

Data transfer This data processing activity includes data transfer to recipients which are certified under the EU-U.S. Data Privacy Framework 

Purpose: If you subscribe, we process your data in order to send you our newsletter. 

Categories of data: Contact details (name, company, e-mail address), business affiliation, market affiliation, service interests 

Legal basis: In accordance with §174 (3) TKG 2021; After giving consent we process your data in accordance with Art 6 (1) (a) GDPR “Consent”. 

Storage period: We store your data until you withdraw your consent. 

Recipients: The Rocket Science Group LLC, 675 Ponce de Leon Ave NE, Suite 5000, Atlanta, GA 30308 USA); see their privacy statement for addtional information 

https://www.intuit.com/privacy/statement/ 

Job application via E-Mail or postal mail 

In a nutshell: When you choose not to apply through our onlyfy-platform we will process your personal data as a sole controller. 

Purpose: Recruitment is necessary for filling the vacant positions in an organization. It sources the candidates with the abilities and attitude which are required for achieving the objectives of an organization. It includes analyzing the job requirements, reviewing applications, screening, shortlisting and selecting the right candidates. 

Categories of data: Name, Contact Details, curriculum vitae, prior positions, education, training certificates, testimonies, Notes of interviewers, additional data provided by the job applicant or collected during recruitment process 

Legal basis: Pre-contractual obligations Art 6 (1) (b) GDPR 

Storage period: Rejected applicants: 7 months 

Customer Relationship Management and Business development 

In a nutshell: We offer our services and tools in a business-to-business context. In this context no products or services are offered to consumers. 

Purpose: The purpose is managing Platomics relationships and interactions with customers and potential customers. It is also used to manage customer relationships across the entire customer lifecycle, spanning marketing, sales, digital commerce, and customer service interactions. It is also used to store customer and prospect contact information, identify sales opportunities, record service issues, and manage marketing campaigns. 

Categories of data: internal identifiers, company details (industry sector, business name, business details, business contact details, public registration ids), contact details of employees or other natural persons associated with the business (name, title, function, postal address including shipping details, e-mail, telephone, messenger-id) 

Legal basis: depending on the relationship we process the data according to Art. 6 Paragraph 1 lit. a GDPR (Consent of the data subject), Art. 6 Paragraph 1 lit. b GDPR (fulfillment of contract), Art. 6 Paragraph 1 lit. c GDPR (legal obligations), Art. 6 Paragraph 1 lit. f GDPR (legitimate interest of controller or third parties) 

Storage period: In general we store your data 7 years. In case additional regulations apply (e.g. medical device regulations) we might be obliged to extend the storage period according to the corresponding law. If the data processing activity is based on your consent, we store your data until you withdraw your consent. 

Activities in a shared responsibility 

Job application via onlyfy-platform 

In a nutshell: When applying for a vacant job position you can use the onlyfy-platform. The usage of this platform is optional. You can apply directly via e-mail or postal mail as a privacy friendly alternative. 

Controllers: Platomics and onlyfy act as shared controllers in this data processing activity. 

Purpose: Platomics wants to target high potentials and recruit new employees on social media platforms and provide a seamless possibility to apply for actual and future job applications 

Transfer to third countries: The platform integrates optional third-party services and social media platforms (e.g., Xing, Facebook, Whatsapp, Google, Meta) which may include transfer of data to third countries, depending on how you use and interact with the onlyfy-platform. Please refer to the privacy policy for details. The usage of this third-party services is optional and based on your consent. 

Categories of data: Name, Contact Details, curriculum vitae, prior positions, education, training certificates, testimonies, Notes of interviewers, additional data provided by the job applicant or collected during recruitment process 

Legal basis: Pre-contractual obligations Art 6 (1) (b) or Consent Art. 6 (1) (a) 

Storage period: Usual storage period for rejected applicants: 7 months; storage period may be extended for other vacant positions based on your consent 

The full privacy policy can be found at https://platomics-gmbh.onlyfy.jobs/policy 

Transfer of data to supervisory authorities, courts and other third parties 

We are subject to numerous legal regulations. In certain cases, we may be legally obliged to disclose personal data of our customers to courts or other authorities upon their request. In any case, we will make sure that the protection of your data is maintained. 

Your rights 

Right of access 

You have the right to request access to your personal data and to obtain information, inter alia, on the purpose of processing, the categories of data concerned, from which source the personal data originate, the recipients of your data, the duration of storage, etc. 

Right to rectification, erasure & restriction of processing

If we process inaccurate or incomplete personal data, you have the right to rectification or completion of such data. You may also request the deletion of the personal data which has been processed unlawfully. Please note that you may exercise these rights only in respect of inaccurate, incomplete or unlawfully processed data. If it is unclear whether your personal data is inaccurate, incomplete, or unlawfully processed you may request us to restrict the processing of your data until this issue has been resolved. 

Please note that these rights complement each other which means that you can request us to either rectify or complete or delete your data.

Right to object 

If we process your data based on our legitimate interest, you have the right to object to the processing of your personal data on grounds relating to your particular situation. If you exercise your right, we will ask you to provide your reasons. You further have the right to object to where we process your personal data for our own purposes. 

Right to revoke consent

If we process your data based on your consent, processing will only take place in accordance with the purposes set out in the separate declaration of consent and to the extent you agreed therein. Any consent given may be revoked at any time with future effect (for example, you may object to the processing of your personal data for marketing and promotional purposes if you no longer consent to processing in the future). 

Right to data portability

In certain cases, you have the right to receive your personal data processed by us in a structured, commonly used and machine-readable format (i.e., right to data portability). Where technically feasible, you may instruct us to transmit your data to a third party of your choice, unless data portability would require unreasonable efforts, affect the rights and freedoms of others or violate any legal obligations. 

Right to appeal 

If you have any concerns regarding data protection law, we hope that you will contact us first and we can address your concerns. However, despite all our efforts to ensure the protection and integrity of your data, you might remain dissatisfied. If you consider that we are unlawfully using your data, you may lodge a complaint with the Austrian Data Protection Authority. 

Supervisory Authority for the compliance with data protection regulations in Austria: 

Österreichische Datenschutzbehörde 

Barichgasse 40-42 

1030 Wien 

Telefon: +43 1 52 152-0 

E: dsb@dsb.gv.at 

W: http://www.dsb.gv.at/