Legal
Effective date: August 7, 2026
These terms govern paid engagements. They are separate from our Terms of Service, which cover use of this website.
These Service Terms govern paid engagements between Vynix LLC, a Wyoming limited liability company doing business as Omakyn ("Omakyn", "we") and the client ("you"). They apply to every service purchased through omakyn.com unless a separately signed agreement says otherwise.
The specific deliverables, revision rounds and turnaround time for each service are published on the service page and are incorporated here by reference. The published scope is the contract.
Omakyn produces cybersecurity documentation and analysis for medical device manufacturers under FDA Section 524B (United States) and the EU Cyber Resilience Act.
These are excluded from every service, at every price:
We do not guarantee clearance, approval, certification, or any particular response from FDA, a notified body, or any other authority. Regulatory decisions are made by the authority on the complete submission, most of which is outside our scope.
We warrant that the work will be performed with the care and skill reasonably expected of a competent practitioner in this field, and that deliverables will address the requirements identified in the published scope. That is the entire warranty.
Published prices assume a device within these limits:
If your device exceeds any of these, we will tell you before you purchase whenever the information is available to us — our free gap analyzer flags it from your answers — and quote separately. If a limit is exceeded and this only becomes apparent after work begins, including because the information you provided was incomplete or inaccurate, we will stop and quote the additional scope. We will not silently absorb it, and we will not proceed without your written approval.
Where you have purchased the tier that includes Deficiency Coverage, and FDA issues a deficiency relating to cybersecurity, we will prepare a response at no additional fee. This coverage is bounded as follows.
Covered: deficiencies that concern the documents Omakyn produced, in the form in which we delivered them.
Not covered:
Duration: coverage applies to the first Additional Information cycle on the submission for which the deliverables were prepared, and expires 12 months after delivery, whichever comes first.
Form of remedy: preparation of a written response to the deficiency. It does not include re-performing the engagement, testing, or engineering work.
The legal obligation to report is yours, not ours. Under the Cyber Resilience Act the manufacturer is the party required to notify ENISA and the relevant CSIRT. Omakyn prepares and assists; Omakyn does not notify on your behalf and is not your legal representative for that purpose.
Our clock is not the regulator's clock. The CRA gives you 24 hours from the moment you become aware of an actively exploited vulnerability or severe incident. Our commitment is:
Business hours means 09:00–18:00 ART, Monday to Friday, excluding Argentine public holidays. We do not provide 24/7 coverage and do not represent that we do. If you require continuous coverage, this service is not suitable and you should say so before purchasing.
Monitoring scope: we monitor published vulnerability sources against the SBOM components you have provided to us, and we are only as current as the SBOM you keep us supplied with. We do not discover vulnerabilities through testing, and we do not monitor components you have not disclosed.
Not included: developing patches, technical remediation, or acting as your point of contact before any authority.
Term: month to month. Either party may cancel with 30 days' written notice. No refund of the current month.
The quality of the work depends on the accuracy of what you give us. You agree to:
Prices are published and payable in USD, in advance, through our payment processor. Prices are exclusive of any taxes that may apply in your jurisdiction.
Refunds: if we have not begun work, a full refund. Once work has begun, fees are non-refundable, except that if we determine we cannot deliver the published scope for reasons attributable to us, we will refund in full.
To the maximum extent permitted by law:
Each party will keep the other's confidential information in confidence and use it only to perform or receive the services. This survives termination for 5 years. Where a separate mutual NDA is signed, that NDA governs and prevails over this section to the extent of any conflict.
We will not name you as a client, publish a case study, or use your logo without your prior written consent.
On full payment, you own the deliverables we produce for you and may use, modify and submit them freely.
We retain ownership of our underlying methods, templates, checklists and know-how, and may reuse them for other clients. Nothing that identifies you or your device is reused.
We may use subprocessors to deliver the service. Where a deliverable is produced with the assistance of automated tools, including AI systems, a qualified human reviews it before delivery. Our current subprocessors are listed in our Privacy Policy.
Either party may terminate an engagement in writing. If you terminate after work has begun, fees already paid are not refunded and we will deliver whatever has been completed. We may suspend or terminate if payment fails or if the information you provide is materially inaccurate.
These terms are governed by the laws of the State of Wyoming, United States, without regard to conflict of law rules. The parties will attempt to resolve any dispute in good faith before commencing proceedings.
We may update these terms. The version in effect at the time of your purchase governs that engagement. Material changes will be dated on this page.
Questions about any of this? Email [email protected] before you purchase, not after.