A PLM (Product Lifecycle Management) device history record (DHR) is a document or set of documents that contains detailed information about a specific device or product. This information can include information such as the device's design, manufacturing, testing, and inspection records, as well as any other relevant information about the device, such as its intended use, instructions for use, and any potential risks associated with its use.
A DHR is typically used to support the regulatory compliance of a medical device or other regulated product. It is a legal requirement for manufacturers of medical devices in many countries, including the United States and the European Union, to maintain DHRs for each device that they manufacture.
In addition to being used for regulatory compliance, DHRs can also be used to support quality control, risk management, and product traceability efforts. For example, they can be used to track changes to a device's design over time, or to identify and address any quality issues that may arise during the device's manufacture or use.
In summary, a PLM device history record (DHR) is a document or set of documents that contains detailed information about a specific device or product, such as the device's design, manufacturing, testing, and inspection records, as well as any other relevant information about the device, such as its intended use, instructions for use, and any potential risks associated with its use. They are typically used to support the regulatory compliance of a medical device or other regulated product, and can also be used to support quality control, risk management, and product traceability efforts.
4059 Basel - Switzerland
Tel. +41 (0)61 361 15 21
Mob. +41 (0)79 408 49 36
VAT#: CHE 451.621.143 MWSt
Platflow PLM: product lifecycle management software, change management software, software bill of materials, workflow management software, revision history software, items management software.
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Technical cookies are those used for the sole purpose of “transmitting a communication over an electronic network, or as strictly necessary for the provider of a WEB service explicitly requested by the user to provide this service”. They are not used for other purposes and are normally installed directly by the owner or manager of the website. They can be divided into navigation or session cookies, in order to guarantee a correct navigation and use of the website. Anonymous analytical cookies allow the creation of aggregate statistics in anonymous form.
Analytical cookies allow us to create detailed statistics on visitors to the website such as, for instance, the display of certain pages, the number of visitors, the time spent on the site by users and how they reach the website.
In order to provide you with additional functions and services within this site, we work with third parties who, independently and not directly controlled by us, may use their cookies to collect information on the activities you have performed while browsing the pages of this site. This information could be used to offer you advertising in line with your interests, based on the content you visit, or to measure the effectiveness of advertising campaigns.
As your privacy is very important to us, we provide you with this Policy, explaining how we collect, use, and share your personal information, so that you can make informed choices about the use of your data.
Lean IT Consulting AG is the data controller. The data controller is the company that decides how and for what purposes your personal data is processed. You can contact us via email: firstname.lastname@example.org.
Our mailing address is: Gundeldingerrain 79 - 4059 Basel, Switzerland.
This website collects data in two ways:
Voluntarily provided data: through contact forms, for example: email address, phone number, name and surname, and professional qualification.
Lean IT Consulting AG also collects data offline, for example, at trade fairs or through other lawful means, such as during negotiations with a customer or supplier. This policy is also addressed to these individuals.
We use the personal data collected for a range of purposes, including the following:
- To sell our products or buy services and products. We also use personal data for internal administrative or legal purposes related to our accounting and records and to inform you of any changes to our services.
- To send marketing communications about our products.
- Compliance with a legal obligation: In some cases, we may have a legal obligation to use or retain your personal data.
- Performance of a contract (or to take steps pre-contractual negotiations);
a) with reference to third-party profiling cookies, the user gives consent in the banner provided by the Cookie Law. Lean IT Consulting AG does not issue its own profiling cookies;
b) to receive marketing communications by mail, email, or phone.
c) for the collection of personal data offline, for example at trade fairs, in order to do direct marketing. In this case, as well as in the case of legitimate interest for soft marketing purposes, at the expiration of the second year, the data controller, if still intends to process the data for marketing purposes, must request a new consent from the data subject.
- Our legitimate interests, in particular:
a) to promote our products (direct marketing).
b) to do soft profiling as permitted by the Working Group Guidelines under Article 29, for example, to understand sales trends of certain products in a particular area. In this type of profiling, the data controller does not carry out invasive treatments and does not cross profiles. Furthermore, the data controller does not provide automated decisions.
If you do not provide us with your personal data, where the transmission of the data is a legal or contractual requirement or a necessary requirement to enter into a contract, we will not be able to enter into the contract.
We do not normally share personal data with third parties. However, there are circumstances in which we are likely to share data with other public authorities and organizations where there is a legal basis for doing so. Such parties are:
- Public authorities
- Tax authorities
- Judicial/investigative authorities such as police, public prosecutors, courts at their express and legal request.
- Our accountant
- Our lawyer
G. WHERE DO WE STORE AND PROCESS YOUR PERSONAL DATA?
We primarily store and process your personal data within the EU/European Economic Area ("EEA"). If we transfer your personal data outside of the EEA, we will do so because there is a legal basis to do so.
Some examples of reasons for which your data may be processed outside of the EEA include:
- Fulfillment of a purchase order.
- Technical support services.
If your personal data cannot be processed within the EEA, we will comply with all other data protection principles.
Where possible, we will transfer your personal data to countries on the list of states that, according to the EU Commission, provide adequate protection for the rights and freedoms of data subjects. In all other cases, in compliance with Article 49 of the GDPR, we will ensure that:
- The transfer is necessary for the performance of a contract between the data subject and the data controller or for the implementation of pre-contractual measures taken at the request of the data subject.
- The transfer is necessary for the conclusion or performance of a contract concluded between the data controller and another natural or legal person for the benefit of the data subject.
H. EXTERNAL DATA PROCESSORS
As far as we are concerned, we have appointed third-party data processors, in particular companies providing administrative and business management services that work on behalf of our company, as external data processors.
For example, regarding tax obligations, our accountant.
You can receive an updated list of these subjects by contacting the data controller.
I. HOW DO WE PROCESS YOUR PERSONAL DATA?
We implement security measures to ensure the maximum protection of your personal data against unauthorized access, modification, disclosure or deletion. Your data is protected by our highly sophisticated security systems.
We actively implement prevention systems to prevent the loss of data or the loss of their confidentiality, their theft as well as their violation, to ensure that our website and the entire IT infrastructure connected to it are updated against the latest network security vulnerabilities.
We assure you that our site incorporates the most advanced security technologies available to ensure the maximum security of its users and the safekeeping of their related information.
L. HOW LONG DO WE RETAIN YOUR PERSONAL DATA?
We will keep your personal data for as long as necessary to fulfill the purposes for which it was collected.
In any case, for tax purposes, we will keep the data for no more than ten years from the end of our contractual relationship.
For marketing purposes, we will keep the data for no more than two years.
M. WHAT ARE YOUR RIGHTS?
- Right of access: you have the right to request a copy of the information we hold about you.
- Right of rectification: you have the right to correct inaccurate or incomplete data we hold about you.
- Right to erasure: in certain circumstances, you may ask for the data we hold about you to be erased from our records.
- Right to restrict processing: in certain circumstances, you have the right to restrict the processing of your personal data.
- Right to data portability: you have the right to have the data we hold about you transferred to another organization.
- Right to object: you have the right to object to certain types of processing, such as direct marketing.
- Right to object to automated processing, including profiling: you also have the right for your data not to be subject to automated processing or profiling.
- Right to lodge a complaint with the supervisory authority.
If you want to exercise any of the above rights, you can write to us at the following email address: email@example.com
N.B: The right of access (as well as the exercise of any other right mentioned above) does not involve the payment of any fee.
Notwithstanding the above, we reserve the right to charge a reasonable fee if your request for access is clearly unfounded or excessive. Alternatively, and only in such circumstance, we may refuse to comply with the request.
M. ADDITIONAL INFORMATION IN COMPLIANCE WITH THE CALIFORNIA CONSUMER PRIVACY ACT
This California Consumer Privacy Act Notice ("Notice") supplements the Lean IT Consulting AG Privacy Notice and is effective as of December 7, 2021.
Categories of personal information collected
The personal information that Lean IT Consulting AG collects, or has collected, from consumers in the twelve months preceding the effective date of this Notice falls within the following categories established by the California Consumer Privacy Act, depending on the use of Lean IT Consulting AG:
- Identifiers such as your name, alias, address, phone numbers, email, or IP address;
- Internet activity information, including information on content interactions, such as content downloads;
- Geolocation data, such as your device or computer location;
- Professional information, such as data you may provide about your business.
Categories of personal information disclosed for a business purpose
Lean IT Consulting does not disclose personal information to third parties.
Right to request access or deletion of personal information
You may have the right under the California Consumer Privacy Act to request information about Lean IT Consulting AG's collection of your personal information, or to request access to or deletion of your personal information.
If you wish to exercise any of these rights, you may contact Lean IT Consulting AG at the following email address: firstname.lastname@example.org or fill out the appropriate contact form.
No sale of personal information
In the twelve months preceding the effective date of this Notice, Lean IT Consulting AG did not sell any personal information of consumers, as provided for by the California Consumer Privacy Act.
Lean IT Consulting AG will not discriminate against any consumer for exercising their rights under the California Consumer Privacy Act.
Cookies or markers are small text files (in practice information packages) that are automatically placed on the navigator's PC or DEVICE inside the browser (Google Chrome, Mozilla Firefox, Microsoft Edge, Safari, etc.) and automatically sent to the server each time the site is accessed. They contain basic information about internet browsing and, thanks to the browser, are recognized each time the user visits the site.
Cookies allow us, in particular, to understand which pages of the site are most visited, as they allow us to see which pages are visited and for how long. Through this data, we are able to make the site more in line with your requests and navigation simpler.
Cookies are divided into three categories:
- Technical cookies: These are packages of information necessary for the display of the website. By law, these cookies do not require consent.
- Analytical cookies: They are considered equivalent to technical cookies by law and, therefore, do not require consent. They can be proprietary to the site (used, for example, to know the number of pages visited within the site) or third-party (i.e., generated by other sites to provide content on the site visited by users).
Users/visitors, however, have the possibility to inhibit the use of Google Analytics and prevent its storage on their device through the appropriate Browser add-on for disabling Google Analytics, provided by Google at https://tools.google.com/dlpage/gaoptout. To activate this component that inhibits the system from sending information about the user/visitor's visit, simply install it by following the instructions on the screen, close and reopen the Browser.
- Profiling cookies: They are aimed solely and exclusively at understanding the preferences of individual users so as to submit them with targeted content during navigation, plausibly of their interest. This site does not release first-party profiling cookies, but third parties may release this type of cookie. For example, you may receive cookies of this type using YouTube video embeds, Facebook's like button, through Google Analytics, or still by using the interactive maps provided by Google Maps.
The most common browsers allow you to exclusively block third-party cookies. To disable this type of cookie, simply follow the instructions provided on the following pages:
as for Firefox: https://support.mozilla.org/it/kb/Attivare e disattivare i cookie
as for Microsoft Edge: https://support.microsoft.com/it-it/help/4027947/windows-delete-cookies
as for Google Chrome: https://support.google.com/chrome/answer/95647?hl=it
as for Opera: https://help.opera.com/en/latest/web-preferences/
as for Apple Safari: https://support.apple.com/it-it/HT201265
Google Ireland Ltd.
Google Analytics: Used to analyze users' use of the site, compile reports on site activities and user behavior, verify how often users visit the site, how the site is tracked, and which pages are most frequently visited. The information is combined with information collected from other sites to create a comparative picture of site usage compared to other sites in the category.
Data collected: browser identifier, date and time of interaction with the website, source page, IP address. Place of data processing: European Union, as the anonymization of the service is active.
When anonymized, as in the case of this website, the Italian Data Protection Authority clarified that they are comparable to technical cookies and therefore do not require the user's consent.
The collected data does not allow for the personal identification of users and is not cross-referenced with other information related to the same person. It is processed in an aggregated and anonymized form (truncated at the last octet). According to a specific agreement (DPA), Google Ireland (the data controller) is prohibited from cross-referencing such data with data obtained from other services.
Further information about Google Analytics cookies can be found on the Google Analytics Cookie Usage on Websites page: https://developers.google.com/analytics/devguides/collection/analyticsjs/cookie-usage.
Users can selectively disable (opt-out) data collection by Google Analytics by installing the appropriate component provided by Google (opt-out) on their browser, which can be downloaded from the following page: https://tools.google.com/dlpage/gaoptout
Youtube: a video-sharing platform owned by Google. Cookies are set when accessing the page containing the embed and when starting the video, and do not allow the identification of the user unless they are already logged in to their Google profile.
For the videos on the website, the "advanced privacy (no cookies)" option has been activated, which ensures that YouTube does not store information about visitors unless they voluntarily play the video.
Data collected: number and behavior of users of the service, IP address, information linking visits to the website to the Google account for users who are already logged in, preferences for video display. Place of data processing: USA.
Social Network Plugins
This website also incorporates plugins and/or buttons to allow for easy sharing of content on your preferred social networks.
When you visit a page on our website that contains a plugin, your browser connects directly to the social network's servers from where the plugin is loaded, which server may track your visit to our website and, if applicable, associate it with your social account, especially if you are logged in at the time of the visit or if you have recently browsed one of the websites containing social plugins.
If you do not want the social network to record data relating to your visit to our website, you must log out of your social account and, possibly, delete the cookies that the social network has installed on your browser.
Plugins with advanced privacy protection functions for users are installed on this website, which do not send cookies or access cookies present on the user's browser when the page is opened, but only after clicking on the plugin. The collection and use of information by such third parties are governed by their respective privacy policies, which should be referred to.
Meta Platforms Ireland Limited (cookie information link): https://www.facebook.com/policies/cookies/
Twitter (cookie information link): https://help.twitter.com/en/rules-and-policies/twitter-cookies
LinkedIn (cookie information link): https://www.linkedin.com/legal/privacy-policy
In addition, according to the GDPR, every website must offer the possibility to easily and immediately disable and/or inhibit cookies, even when they are anonymous or do not involve the recording of personally identifying data, such as IP addresses.
As already stated in the "legal basis" section, the use of profiling cookies is allowed or can be disabled by expressing your preference, also by clicking on the dedicated banner that appears when accessing the website.