Table of contents
4.2 What do we do with your personal information?. 3
4.3 Sharing your personal data. 3
4.4 Retention of your personal information. 3
1 Scope
| Date | Revision Description | Approval Status | Signature |
| 20242310 | Audio3 Ltd. Document Template – Risk Severity 3 | Approved* | |
| 20260215 | Audio3 Ltd Privacy Policy | Approved* |
*Approvable without review
DHF – Document History File. A group of documents that contain information about how the medical product was developed as required [10] (EndNote Keyword DHF).
UEF – Usability Engineering File. A group of documents that contain information the development of the User Interface as required [10] (EndNote Keyword UEI).
DMR – Device Master Record. A group of documents that contain information on how to produce current and past versions of the device as required [10] (EndNote Keyword DMR).
TRM – Technical Reference Manual – A product level reference manual that contains explanations of the architecture, detailed design and reasoning, verification protocols and test results. This is a living document that is updated throughout the lifecycle of the product.
RMF – Risk Management File. A group of documents that contain information about the product risks and their mitigation controls and implementation of those as required [2] (EndNote Keyword RMF).
MDR – Medical Device Regulations [9]
VRA – Visually Reinforced Audiometry
AR – Asset Register [11]. An Audio3 Database Table with the title ‘Asset Register’. Contains all the Assets of the business that go into making a product. This table is global (covers all products) and is regularly updated, it contains both assets (e.g. parts, software, tools) designed by Audio3 and those bought via suppliers.
SR – Specification Register [12]. An Audio3 Database Table with the title ‘Specification Register’. Contains all the requirements and specifications, and links those to their evidence data by reference (typically evidence is in the TRM). This table is global (covers all products) and is regularly updated.
RR – Risk Register [13]. An Audio3 Database Table with the title ‘Risk Register’. Contains all the risks required by the risk management plan. This table is global (covers all products) and is regularly updated.
ER – Event Register [14]. Audio3 Database Table with the title ‘Event Register’. Contains all the Events (warrantee repair, complaint, use feedback, bug discovery). This table is global (covers all products) and is regularly updated.
Business Effect – A potential harm or benefit to the business. Many things can give rise to business effects such as: (1) a regulatory problem, (2) a business process that is too complicated or costly to support, (3) a product defect, (4) a new competitive advantage.
PP – Product Plan
IFU – Instructions for Use
SDP – Software Development Plan
RMP – Risk Management Plan
UP – Usability Plan
DCP – Data and Cyber Plan
FMEA – Failure Mode Effect Analysis
CPA – Critical Point Analysis
FTA – Fault Tree Analysis
This statement sets out what information we collect, store and what we do with it.
In order for Audio3 Limited to process orders, carry out functions and activities, we need to collect certain first party information. The information we collect can be categorised as follows:
- Personal details including names and titles
- Company details
- Preferred contact details such as postal address, email, and telephone numbers
- Files uploaded for printing
- A record of previous orders, including delivery addresses, email addresses, phone numbers and transactional details associated with the order.
Audio3 may also collect information about its users through the following sources that include:
- directly from you, when you submit a form
- from external monitoring services such as Google Analytics
- through the use of cookies
- through reports on the traffic registered by the server hosting our website
- IP address
When you visit a website and accept cookies you reveal information such as your IP address, the time of your visit, the location you accessed the website from or information about the device you used (such as the type of browser, type of device etc.). Audio3, same as other operators, registers such data for the purpose of improving the user experience and the quality of our services ,and also for re-targeting campaigns. Any statistics, that we send to third parties such as Google Analytics, regarding our user traffic are provided only as aggregated data, without any personally identifiable information.
Google Ads session – no personal or company information is sent back to Google Ads. We do include an internal order reference number when information is pushed to Google ads during an ads session. The reference number is completely anonymous to Google’s data. The reference number can only be identified and processed by our own internal ordering system on our protected servers.
4.2 What do we do with your personal information?
We promise to respect any personal data you share with us, keep it safe and will not do anything that you would not reasonably expect. Below we explain what we do with your data and our legal basis for carrying out these processes:
Legitimate Interest – We have identified these activities as a necessary function of Audio3 Limited. Unless you tell us otherwise, we will:
- Store the information you have provided us in a safe and responsible manner
- Send you updates about open orders you may have with us
- Store your previous orders and associated details
- Track your engagement with us so we can provide you with an improved and more suitable service
- Consent – With your permission, we will:
- Email you invitations to events
- Email you with other relevant marketing material relating to Audio3
4.3 Sharing your personal data
The Data Protection Act exists to protect the rights and privacy of an individual’s personal data. Audio3 Limited is committed to this, and it should be noted that spouses, parents and friends have no automatic right of access to your personal data. However, there are occasions when Audio3 Limited is obliged by law to disclose your personal data to external people or agencies. These are sometimes called third party disclosures. Audio3 Limited will check that the disclosure is appropriate and that the third party is legitimate before any release takes place. These third parties are described as follows:
- Legal Authorities and Law Enforcement: Where disclosure is necessary for the prevention or detection of crime, Audio3 Limited will release your information where necessary to these authorities.
- Service providers: Audio3 Limited may use services such as mailing houses under contract for relevant operations.
- Audio3 Limited remains the Data Controller at all times.
4.4 Retention of your personal information
We will retain your personal information for as long as you maintain a relationship with Audio3 Limited or until you inform us otherwise. When your relationship with us ends, we will ensure your personal data is removed. Some data such as any orders made with us, will be retained for record keeping in accordance with accounting best-practice and our legal obligations.
How do we store your data and keep it safe?
Audio3 Limited stores all client data only in files that are password protected with restricted access only to those staff that need that information and are not communicated internally (e.g. via email). All transactions made via our online checkout system are processed securely by a PCI-DSS compliant secure payment gateway service. No bank or payment details are retained after the transaction is complete, which is a key requirement for PCI compliance.
How do we use cookies?
Cookies are small text files that can be used by websites to make a user’s experience more efficient.
The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission.
This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
Our website is lightweight but it does use ‘cookies’ on your own computer to work as needed. You can opt out of using cookies by declaring this when you arrive. You can also delete your cookies and then change this preference by visiting the site again.
Your rights?
The Data Protection Act is in place to enable you to control how Audio3 Limited and other organisations use your data. It is important to us that you know your rights and that you may:
- request a copy of the information we hold about you
- update or amend the information we hold about you if it is incorrect
- change your communication preferences at any time
- ask us to remove your personal information from our records
- object to the processing of your information for marketing purposes
- raise a concern or complaint about the way in which your information is being used
If you choose to unsubscribe from communications from us, we will update our records to stop further communication as quickly as we can. Due to some communications that may already being in progress at the point you opt out, please be aware that it can take up to six weeks for your preferences to be fully implemented.
You have the right to access the information that Audio3 Limited holds on you. This is called a Subject Access Request (SAR) and you will be requested to provide proof of identity.
What happens when I follow links on the site?
If you follow links to other sites from our website once you are on that site, your data will be subject to the privacy policies of those sites. You should refer to these policies before providing your data on those sites.
What happens when this policy changes?
Changes may be necessary to this policy to reflect legal or data processing developments. If we change the policy we will update this information on our website so that users can review the changes. Any significantly different use of your data will be communicated to you and you will be able to choose whether you agree to it.
How you can contact us
We are always happy to hear your views on what we are doing well and if you have any compliments or comment on the work Audio3 Limited does. We of course also welcome your complaints and comments and you can contact us at the following address: Audio3 Limited, 2 Rosamond St, London SE26 6JR.