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Logo ProMeduSec Cybersecurity and Software processes for medical devices in Munich


Process consulting for Cybersecurity, Software and Tools.
Lean and in compliance with
ISO80001-5-1, IEC62304, ISO13485 and FDA guidances.

What We Do

ProMeduSec specializes in the implementation of cybersecurity lifecycle processes, software lifecycle management processes, and software tool validation specifically tailored for medical device companies.
ProMeduSec understands that processes must be lean and manageable, allowing medical device manufacturers to focus on their products rather than the processes.

What We Stand For

Streamlined and easily manageable processes are crucial for:
* Medical device manufacturers with existing products on the market.
* Startups with limited resources.
ProMeduSec brings expertise in implementing processes that minimize overhead while ensuring full compliance with regulations, guidance, and directives.

Cybersecurity Processes

Cybersecurity is increasingly critical in today's environment. Over recent years, regulatory bodies like the FDA and EU have issued multiple guidelines and directives highlighting the need for robust cybersecurity processes throughout the lifecycle of medical devices.
While cybersecurity in medical devices is essential, the introduction of numerous new cybersecurity requirements can impose significant challenges.
Additionally, cybersecurity may not be the core expertise of most medical device manufacturers.
ProMeduSec emphasizes the development of lean and straightforward processes that align with ISO80001-5-1 and FDA guidelines.
This approach is particularly beneficial for startups and for established medical device manufacturers with products already on the market.

Software Lifecycle Processes

Leveraging extensive experience in medical device software development, ProMeduSec assists startups and small companies in establishing lean, agile processes that are fully compliant with IEC62304.

Integrated Cybersecurity and Software Lifecycle Processes

ProMeduSec excels in implementing integrated cybersecurity and software lifecycle processes. This solution is particularly valuable for smaller software teams or startups, where resources may be limited.

Software Tool Validation Processes

ProMeduSec provides expert guidance in establishing software tool validation processes. This approach ensures that focus remains on the most critical software tools while maintaining minimal documentation for others, all in compliance with ISO13485.

Custom made tools for requirement and test tracing

As projects grow and evolve, the number of requirements and corresponding test cases also increases. Often, requirements are documented in various formats such as .doc, .docx, .xlsx, or .html, which can be difficult to manage.
While requirement tracing platforms offer a solution, they are often expensive and integrating existing requirements can be challenging.
The representation of requirements, tests, and their relationships in original documents is often inconsistent and proprietary.
ProMeduSec offers custom tools that enable effective tracing of requirements and tests without altering the original documents.

Contact

Email: info@promedusec.com
Phone: +49 176 32470663
Dipl. Ing. (BA) Ludwig Hiller
Auer Str. 10b
83707 Bad Wiessee
Germany

Privacy Policy

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1. Overview of Data Protection

General Information

The following information provides a simple overview of what happens to your personal data when you visit our website. Personal data is any data that can be used to personally identify you. For detailed information on data protection, please refer to our privacy policy listed below.

Data Collection on Our Website

Who is responsible for data collection on this website?

The data processing on this website is carried out by the website operator. You can find the operator's contact details in the “Notice Regarding the Responsible Party” section of this privacy policy.

How do we collect your data?

On the one hand, your data is collected when you provide it to us. This could be, for example, data that you enter into a contact form.

Other data is automatically collected or with your consent when you visit the website through our IT systems. This mainly includes technical data (e.g., internet browser, operating system, or time of page access). The collection of this data happens automatically as soon as you enter our website.

What do we use your data for?

Part of the data is collected to ensure the proper functioning of the website. Other data may be used to analyze your user behavior.

What rights do you have regarding your data?

You have the right to receive information about the origin, recipient, and purpose of your stored personal data at any time, free of charge. You also have the right to request the correction or deletion of this data. If you have consented to data processing, you can withdraw this consent at any time for the future. Furthermore, you have the right to request the restriction of the processing of your personal data under certain circumstances. You also have the right to lodge a complaint with the competent supervisory authority.

For further questions regarding data protection, you can contact us at any time.

2. Hosting

We host the content of our website with the following provider:

External Hosting

This website is hosted externally. The personal data collected on this website is stored on the servers of the hosting provider. This may include IP addresses, contact requests, metadata and communication data, contract data, contact details, names, website accesses, and other data generated through a website.

External hosting is conducted for the purpose of fulfilling our contractual obligations towards our potential and existing customers (Art. 6 para. 1 lit. b GDPR) and in the interest of a secure, fast, and efficient provision of our online offering by a professional provider (Art. 6 para. 1 lit. f GDPR). If consent has been requested, processing is carried out exclusively on the basis of Art. 6 para. 1 lit. a GDPR and § 25 para. 1 TTDSG, insofar as the consent includes the storage of cookies or access to information on the user’s device (e.g., device fingerprinting) within the meaning of the TTDSG. The consent can be revoked at any time.

Our hosting provider(s) will process your data only to the extent necessary to fulfill their performance obligations and follow our instructions regarding this data.

We use the following hosting provider:

Hostinger International Ltd.
61 Lordou Vironos Street
6023 Larnaca
Cyprus

3. General Information and Mandatory Information

Data Protection

The operators of this site take the protection of your personal data very seriously. We treat your personal data confidentially and in accordance with the statutory data protection regulations and this privacy policy.

When you use this website, various personal data is collected. Personal data is data with which you can be personally identified. This privacy policy explains which data we collect and what we use it for. It also explains how and for what purpose this happens.

Please note that data transmission over the internet (e.g., communication by email) may have security vulnerabilities. A complete protection of data against third-party access is not possible.

Notice Regarding the Responsible Party

The responsible party for data processing on this website is:

Dipl. Ing. (BA) Ludwig Hiller
Auer Str. 10b
83707 Bad Wiessee
Germany

Phone: +49 176 32470663
Email: info@promedusec.com

The responsible party is the natural or legal person who alone or jointly with others determines the purposes and means of processing personal data (e.g., names, email addresses, etc.).

Storage Duration

Unless a specific storage period is stated within this privacy policy, your personal data will remain with us until the purpose for the data processing no longer applies. If you make a legitimate request for deletion or withdraw your consent to data processing, your data will be deleted unless we have other legally permissible reasons for storing your personal data (e.g., tax or commercial retention periods); in such cases, the data will be deleted once these reasons no longer apply.

General Information on the Legal Basis of Data Processing on This Website

If you have consented to data processing, we process your personal data based on Art. 6 para. 1 lit. a GDPR or Art. 9 para. 2 lit. a GDPR if special categories of data are processed according to Art. 9 para. 1 GDPR. In the case of explicit consent to transfer personal data to third countries, data processing is also based on Art. 49 para. 1 lit. a GDPR. If you consented to the storage of cookies or access to information on your device (e.g., via device fingerprinting), data processing is additionally based on § 25 para. 1 TTDSG. The consent can be revoked at any time. If your data is necessary for fulfilling a contract or carrying out pre-contractual steps, we process your data based on Art. 6 para. 1 lit. b GDPR. Further, we process your data when required to fulfill a legal obligation based on Art. 6 para. 1 lit. c GDPR. Data processing may also be carried out on the basis of our legitimate interest under Art. 6 para. 1 lit. f GDPR. The specific legal basis applicable in each case is outlined in the following sections of this privacy policy.

Recipients of Personal Data

In the course of our business activities, we work with various external parties. This may require the transmission of personal data to these external parties. We only share personal data when necessary to fulfill a contract, if we are legally obliged to do so (e.g., sharing data with tax authorities), if we have a legitimate interest under Art. 6 para. 1 lit. f GDPR in sharing the data, or if another legal basis permits data sharing. When using processors, we share our customers' personal data only based on a valid processing agreement. In the case of joint processing, a joint processing agreement is concluded.

Revocation of Your Consent to Data Processing

Many data processing operations are only possible with your express consent. You may revoke consent already given at any time. The legality of the data processing carried out until the revocation remains unaffected by the revocation.

Right to Object to Data Collection in Special Cases and to Direct Marketing (Art. 21 GDPR)

IF DATA PROCESSING IS BASED ON ART. 6 PARA. 1 LIT. E OR F GDPR, YOU HAVE THE RIGHT TO OBJECT TO THE PROCESSING OF YOUR PERSONAL DATA AT ANY TIME FOR REASONS ARISING FROM YOUR PARTICULAR SITUATION; THIS ALSO APPLIES TO PROFILING BASED ON THESE PROVISIONS. THE RESPECTIVE LEGAL BASIS ON WHICH PROCESSING IS BASED CAN BE FOUND IN THIS PRIVACY POLICY. IF YOU OBJECT, WE WILL NO LONGER PROCESS YOUR PERSONAL DATA UNLESS WE CAN DEMONSTRATE COMPELLING LEGITIMATE GROUNDS FOR THE PROCESSING THAT OVERRIDE YOUR INTERESTS, RIGHTS, AND FREEDOMS OR THE PROCESSING IS FOR THE ESTABLISHMENT, EXERCISE, OR DEFENSE OF LEGAL CLAIMS (OBJECTION UNDER ART. 21 PARA. 1 GDPR).

IF YOUR PERSONAL DATA IS PROCESSED FOR DIRECT MARKETING PURPOSES, YOU HAVE THE RIGHT TO OBJECT TO THE PROCESSING OF YOUR PERSONAL DATA FOR SUCH MARKETING AT ANY TIME; THIS ALSO APPLIES TO PROFILING INSOFAR AS IT IS ASSOCIATED WITH SUCH DIRECT MARKETING. IF YOU OBJECT, YOUR PERSONAL DATA WILL NO LONGER BE USED FOR DIRECT MARKETING PURPOSES (OBJECTION UNDER ART. 21 PARA. 2 GDPR).

Right to File Complaints with Regulatory Authorities

If there are any violations of the GDPR, affected individuals have the right to lodge a complaint with a supervisory authority, particularly in the member state of their habitual residence, their place of work, or the place of the alleged infringement. The right to lodge a complaint is without prejudice to any other administrative or judicial remedy.

Right to Data Portability

You have the right to have data that we process automatically on the basis of your consent or in fulfillment of a contract delivered to you or a third party in a common, machine-readable format. If you request the direct transfer of data to another controller, this will only occur if it is technically feasible.

Information, Rectification, and Erasure

Within the scope of applicable legal provisions, you have the right to obtain information about your stored personal data, its origin, and recipients, and the purpose of data processing at any time, as well as a right to rectification or deletion of this data, if applicable. For further questions on personal data, you can contact us at any time.

Right to Restrict Processing

You have the right to request the restriction of the processing of your personal data. You can contact us for this purpose at any time. The right to restrict processing exists in the following cases:

  • If you contest the accuracy of your personal data stored with us, we usually need time to verify this. For the duration of the verification, you have the right to request the restriction of the processing of your personal data.
  • If the processing of your personal data was/is unlawful, you can request the restriction of data processing instead of deletion.
  • If we no longer need your personal data but you require it for the establishment, exercise, or defense of legal claims, you have the right to request the restriction of the processing of your personal data instead of deletion.
  • If you have objected under Art. 21 para. 1 GDPR, a balance must be struck between your interests and ours. As long as it is not clear whose interests prevail, you have the right to request the restriction of the processing of your personal data.

If you have restricted the processing of your personal data, this data may – apart from its storage – only be processed with your consent or for the establishment, exercise, or defense of legal claims or for protecting the rights of another natural or legal person or for reasons of important public interest of the European Union or a member state.

Source: https://www.e-recht24.de