Data protection declaration
Data protection
As the operator of this website, we take the protection of your personal data very seriously. We treat your personal data confidentially and in accordance with the provisions of the applicable data protection legislation as well as with this data protection declaration.
In general, our website can be used without providing any personal data. If personal data are collected on our pages (e.g., name, address or email address), this is done on a voluntary basis as far as possible. The data will not be disclosed to third parties without your explicit consent.
Please note that data transmitted via the internet (e.g., when communicating by email) may be subject to security breaches. Complete protection of data against access by third parties is not possible.
Data protection declaration for the use of LinkedIn
Our site uses functions of the LinkedIn network. The provider is the LinkedIn Corporation, 2029 Stierlin Court, Mountain View, CA 94043, USA. Each time one of our pages containing LinkedIn functions is accessed, your browser establishes a connection to LinkedIn servers. LinkedIn is informed that you have visited our Internet pages with your IP address. If you use the LinkedIn "Recommend" button and are logged into your LinkedIn account, it is possible for LinkedIn to associate your visit to our Internet website with your user account. As the provider of this website, we expressly point out that we receive no information about the content of the transmitted data or its use by LinkedIn.
Further information about this can be found in LinkedIn's data protection declaration under:https://www.linkedin.com/legal/privacy-policy
Data protection declaration for the use of YouTube
Our website uses plugins from YouTube, which is operated by Google. The operator of the pages is YouTube LLC, 901 Cherry Ave., San Bruno, CA 94066, USA. If you visit one of our pages that have a YouTube plugin, a connection to the YouTube servers is established. In this case, the YouTube server is informed about which of our pages you visited.
If you are logged into your YouTube account, you allow YouTube to directly associate your surfing habits with your personal profile. You can prevent this by logging out of your YouTube account.
Further information about handling user data can be found in the data protection declaration of YouTube at: https://www.google.de/intl/de/policies/privacy
Information, deletion, blocking
You have the right to request information on any stored personal data as well as its origin, the recipient, and the purpose of data processing at any time and free of charge. You also have the right to have this data corrected, blocked or deleted. You can contact us at any time at the address given in the legal information if you have further questions on the topic of personal data.
Cookies
Some of our webpages use so-called cookies. Cookies do not harm your computer and do not contain any viruses. Cookies help make our range of services more user-friendly, efficient, and secure. Cookies are small text files that are stored on your computer and saved by your browser.
Most of the cookies we use are known as "session cookies". They are automatically deleted at the end of your visit. Other cookies remain in your device's memory until you delete them. These cookies enable us to recognize your browser when you next visit the site.
You can configure your browser in such a way that you are informed about the use of cookies and only allow cookies in individual cases, accept cookies under certain conditions, generally reject them, or automatically delete cookies when closing your browser. If cookies are deactivated, the functionality of this website may be limited.
Server log files
The website provider automatically collects and stores information that your browser automatically transmits to us in "server log files". This includes:
- Browser type/version
- Operating system
- Referrer URL
- Host name of accessing computer
- Time of server request
These data cannot be assigned to specific persons. This data is not combined with data from other sources. We reserve the right to retrospectively examine this data in the event of concrete evidence of illegal activity.
Contact form
If you send us questions via the contact form, we will store your details from the request form including the contact details you provide for the purpose of answering your questions and any follow-up questions. This data is not disclosed to third parties without your express consent.
Objection to promotional emails
We hereby expressly prohibit the use of the contact data, which is published to comply with legal notice requirements, for the purpose of sending promotional and informational materials that are not expressly requested. The website operators reserve the right to take specific legal action in the event that unsolicited advertising material, such as spam email, is received.
Newsletter data
If you wish to receive our newsletter, we require a valid email address as well as information allowing us to verify that you are the owner of the specified email address and that you agree to receive this newsletter. No additional data is collected. We only use this data to send the requested information and do not forward it to third parties.
You can revoke your consent to the storage of your data and email address as well as their use for sending the newsletter at any time, e.g., via the email "steffen.ritzal(at)gelitamedical.com".
Usage of Google Analytics
This website uses Google Analytics, a web analytics service provided by Google, Inc. (“Google”). Google Analytics uses “cookies”, which are text files placed on your computer, to help the website analyze how users use the site. The information generated by the cookie about your use of the website will be transmitted to and stored by Google on servers in the United States .
In case IP-anonymisation is activated on this website, your IP address will be truncated within the area of Member States of the European Union or other parties to the Agreement on the European Economic Area. Only in exceptional cases the whole IP address will be first transferred to a Google server in the USA and truncated there. The IP-anonymisation is active on this website.
Google will use this information on behalf of the operator of this website for the purpose of evaluating your use of the website, compiling reports on website activity for website operators and providing them other services relating to website activity and internet usage.
The IP-address, that your Browser conveys within the scope of Google Analytics, will not be associated with any other data held by Google. You may refuse the use of cookies by selecting the appropriate settings on your browser, however please note that if you do this you may not be able to use the full functionality of this website. You can also opt-out from being tracked by Google Analytics with effect for the future by downloading and installing Google Analytics Opt-out Browser Addon for your current web browser: http://tools.google.com/dlpage/gaoptout?hl=en.
As an alternative to the browser Addon or within browsers on mobile devices, you can click this link in order to opt-out from being tracked by Google Analytics within this website in the future (the opt-out applies only for the browser in which you set it and within this domain).
Information, deletion, blocking
You have the right to request information on any stored personal data as well as its origin, the recipient, and the purpose of data processing at any time and free of charge. You also have the right to have this data corrected, blocked or deleted. You can contact us at any time at the address given in the legal information if you have further questions on the topic of personal data or directly.
Via Mail:
quality(at)gelitamedical.com
Postal:
Samy Jandali
Uferstraße 7
69412 Eberbach
GERMANY
Post-Market Surveillance Medical Devices
- Information according to Article 13 and 14 General Data Protection Regulation (GDPR) -
If you fill out our PMS feedback questionnaires, we will inform you of the following in accordance with the General Data Protection Regulation (GDPR):
1. Responsible person and contact details
Name and contact details of the responsible person
Samy Jandali
GELITA MEDICAL GmbH
Managing Director
Uferstr. 7
69412 Eberbach
Germany
Phone: +49 (6271) 8401
Email: quality@gelitamedical.com
2. Information on the processing of the data
Processing purposes and legal basis
The data collected as part of the questionnaire on the use of medical devices is used for the following purposes:
- Name of physician and hospital:
for questions about reported complications when using the medical device - Name of the person who completed the questionnaire:
to confirm that all questions have been answered to the best of his/her knowledge (or on behalf of the physician and with his consent). - Technical information on the use of medical devices:
for the clinical evaluation of the product with regard to safety and performance
All questionnaires are evaluated annually in anonymized form (percentage evaluation of how many participants made which statements).
Legal basis for processing
- the name of the physician and the person who completed the questionnaire:
Article 6 paragraph 1 a GDPR (consent), - the technical information on the use of medical devices:
Article 6 paragraph 1 c GDPR (to fulfill a legal obligation to which the responsible person is subject) in conjunction with Article 83 of Regulation (EU) 2017/745 on medical devices.
Duration of storage
The data is continuously collected over the life of the medical product, since in addition to the annual analyzes, overall analyzes are also created for the individual products. A deletion therefore only takes place when the product is no longer on the market and no overriding legal regulation requires further storage of the data.
Data recipient
The analysis is incorporated into the clinical evaluation and is therefore also made available to the responsible certification body (“Notified Body”).
In the event of an audit, the “Notified Body” can also request access to the source data and in this case has access to the names given in the questionnaires.
Authorized read access to the platform on which the questionnaires are saved is given not only to the responsible GELITA MEDICAL employees, but also to the provider's support and distributors who are authorized by GELITA MEDICAL to act as distributors for GELITA MEDICAL in their respective country.
3. Your rights
You are informed about your rights to information, correction, deletion, restriction of processing, objection to processing and the right to data portability, which result from Articles 15 to 21 GDPR.
If the data processing is based on your consent, you have the right to withdraw your consent at any time without affecting the legality of the processing carried out on the basis of the consent up to the withdrawal.
To exercise your rights and if you have any further questions about data protection, you can contact us at any time at the address given above (see point 1) (to the responsible person or to the data protection officer).
Furthermore, according to Article 77 GDPR, you have the right to complain to the competent supervisory authority (State Commissioner for Data Protection and Freedom of Information (LfDI) Baden-Württemberg, Stuttgart / Germany).