Terms of Service
VigilaMed Ltd
Last Updated: January 2026
1. Introduction
These Terms of Service ("Terms," "Agreement") govern the relationship between VigilaMed Ltd ("VigilaMed," "we," "us," or "our"), a company registered in Scotland, United Kingdom, and you ("Client," "you," or "your") regarding the provision of Quality & Regulatory Affairs (QARA) consultancy services.
By engaging with our services, visiting our website, entering into a service agreement, or accepting a Statement of Work (SOW), you acknowledge that you have read, understood, and agree to be bound by these Terms of Service. If you do not agree to these Terms, you must not use our services.
These Terms, together with any executed service agreements, Statements of Work, and confidentiality agreements, constitute the entire agreement between you and VigilaMed regarding the provision of consultancy services.
2. Nature of Services
VigilaMed provides regulatory consultancy services, quality management system (QMS) advisory, mock auditing, gap analysis, regulatory submission support, and related professional services to medical device manufacturers.
Advisory Services Only:
Our services are advisory in nature and do not constitute legal advice. We provide consultancy, frameworks, methodologies, and guidance to assist clients in understanding regulatory requirements, preparing quality management systems, and developing regulatory submissions. We do not provide legal representation, legal opinions, or legal services.
Our services may include, but are not limited to:
- Quality Management System (QMS) development, implementation, and improvement
- Regulatory strategy and submission support (FDA 510(k), PMA, CE marking, UKCA, MDSAP)
- Mock audits, gap analysis, and compliance assessments
- Regulatory training and staff development
- Post-market surveillance and vigilance support
- Risk management (ISO 14971) guidance
- Clinical evaluation and documentation support
The specific scope of services, deliverables, timelines, and fees for each engagement will be detailed in a separate service agreement or Statement of Work (SOW), which will be incorporated by reference into these Terms.
3. No Guarantee of Regulatory Outcomes
VigilaMed strives to provide high-quality consultancy services and to assist clients in achieving regulatory compliance. However, we do not guarantee, warrant, or promise any specific regulatory outcomes, approvals, certifications, or decisions.
Critical Disclaimer:
- Regulatory decisions, including FDA approvals, Notified Body certifications, and regulatory authority determinations, are outside our control. Such decisions are made solely by regulatory authorities (e.g., FDA, MHRA, EU Notified Bodies) based on their independent assessment of client submissions and compliance.
- VigilaMed is not liable for rejected submissions, FDA Form 483 observations, Warning Letters, regulatory non-compliance, or any adverse regulatory actions.
- While we strive for 100% compliance and zero major audit findings, regulatory outcomes cannot be guaranteed. Compliance is influenced by numerous factors beyond our control, including client implementation, device-specific requirements, regulatory authority interpretations, and changes in regulations.
- The client retains final legal and regulatory responsibility for their medical device, submissions, quality management system, and regulatory compliance.
Clients acknowledge that regulatory compliance and approval processes involve inherent uncertainty, and that VigilaMed's services are advisory and educational in nature. Clients are responsible for implementing our recommendations, conducting their own due diligence, and making final decisions regarding regulatory strategies and submissions.
We recommend that clients consult with qualified legal counsel and regulatory attorneys for legal advice regarding regulatory compliance, submissions, and liability.
4. Intellectual Property Rights
4.1 VigilaMed Intellectual Property
All intellectual property rights, including but not limited to copyrights, trademarks, trade secrets, methodologies, frameworks, protocols, templates, tools, and proprietary knowledge developed by VigilaMed or provided by VigilaMed in the course of our services, remain the exclusive property of VigilaMed Ltd.
Proprietary Frameworks:
The "VigilaMed Inspection Choreography Protocol" and all associated frameworks, methodologies, templates, checklists, and proprietary processes are the intellectual property of VigilaMed. These materials are protected by copyright, trade secret, and other intellectual property laws.
Clients are granted a non-exclusive, non-transferable, limited license to use these materials solely for internal compliance purposes within the client's organization and only in connection with the specific engagement for which they were provided.
Clients may not:
- Copy, reproduce, distribute, or share VigilaMed's proprietary materials with third parties without express written permission
- Use VigilaMed's methodologies, frameworks, or protocols to provide competing consultancy services
- Reverse engineer, decompile, or create derivative works based on VigilaMed's proprietary materials
- Remove or alter any copyright notices, trademarks, or proprietary markings on VigilaMed's materials
4.2 Client Intellectual Property
Client-owned information, data, documentation, trade secrets, and intellectual property (including device designs, technical files, and proprietary processes) shared with VigilaMed remain the property of the client. VigilaMed will use such materials solely for the purpose of providing consultancy services and will maintain confidentiality in accordance with Section 5 (Confidentiality) and any applicable non-disclosure agreements.
4.3 Work Product
Deliverables and work product created specifically for a client in the course of an engagement (e.g., customized QMS documentation, client-specific regulatory submissions, tailored training materials) will be owned by the client, subject to VigilaMed's retention of a non-exclusive license to use anonymized, aggregated data and methodologies for internal quality improvement and benchmarking purposes. Underlying frameworks, methodologies, and templates used in creating such deliverables remain VigilaMed's intellectual property.
5. Limitation of Liability
Liability Cap:
VigilaMed's total aggregate liability to the client for all claims, losses, damages, costs, and expenses arising from or related to our services, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, shall not exceed the total fees paid by the client to VigilaMed in the twelve (12) months immediately preceding the date on which the claim arose.
This limitation applies to:
- Direct, indirect, consequential, incidental, special, or punitive damages
- Loss of profits, revenue, business opportunities, or goodwill
- Regulatory non-compliance, rejected submissions, FDA 483 observations, Warning Letters, or adverse regulatory actions
- Loss of or damage to data, documentation, or intellectual property
- Delays, errors, or omissions in service delivery
Nothing in these Terms excludes or limits VigilaMed's liability for:
- Death or personal injury caused by our negligence
- Fraud or fraudulent misrepresentation
- Any other liability that cannot be excluded or limited under applicable law
Clients acknowledge that the fees charged by VigilaMed reflect the limitation of liability set forth in this section, and that clients may obtain additional insurance or legal protections if desired.
6. Confidentiality
Both VigilaMed and the client acknowledge the sensitive and proprietary nature of information shared in the course of our consultancy relationship. Both parties agree to maintain confidentiality and protect each other's trade secrets, proprietary information, and confidential materials.
Mutual Non-Disclosure:
- VigilaMed will protect the client's trade secrets, proprietary information, regulatory documentation, and confidential business information shared with us in the course of our engagement. We will use such information solely for the purpose of providing consultancy services and will not disclose it to third parties without the client's express written consent, except as required by law or regulatory authority.
- The client will protect VigilaMed's proprietary methodologies, frameworks, protocols, trade secrets, and confidential business information (including the "VigilaMed Inspection Choreography Protocol" and associated frameworks) shared with the client. The client will not disclose, copy, or use such information except as expressly permitted under Section 4 (Intellectual Property Rights) and any applicable service agreements.
Confidential information includes, but is not limited to:
- From Client to VigilaMed: Device designs, technical files, regulatory submissions, quality management system documentation, trade secrets, business strategies, financial information, and proprietary processes
- From VigilaMed to Client: Proprietary frameworks, methodologies, protocols, templates, tools, internal processes, pricing structures, and business strategies
Confidentiality obligations shall survive termination of the engagement and shall continue for a period of five (5) years after the last disclosure of confidential information, except for trade secrets, which shall remain confidential indefinitely until they become publicly available through no breach of these Terms.
These Terms supplement, but do not replace, any separate Non-Disclosure Agreement (NDA) or Confidentiality Agreement executed between the parties. In case of conflict, the terms of the separate NDA shall govern with respect to confidentiality obligations.
7. Fees and Payment Terms
Fees for VigilaMed's services will be specified in the applicable service agreement or Statement of Work (SOW). Fees are exclusive of applicable taxes, which shall be the responsibility of the client.
Unless otherwise specified in the service agreement or SOW:
- Invoices are due within thirty (30) days of the invoice date
- Late payments may be subject to interest charges at a rate of 1.5% per month or the maximum rate permitted by law, whichever is lower
- VigilaMed reserves the right to suspend or terminate services in the event of overdue invoices
- All fees are non-refundable except as expressly stated in the service agreement or as required by law
8. Termination
Either party may terminate an engagement in accordance with the terms specified in the service agreement or Statement of Work (SOW). In the absence of specific termination provisions, either party may terminate an engagement with thirty (30) days' written notice to the other party.
VigilaMed may terminate services immediately in the event of:
- Non-payment of fees
- Material breach of these Terms or the service agreement
- Client's use of our services for illegal or unethical purposes
- Any other circumstances that make continuation of the engagement untenable
Upon termination, the client shall pay all outstanding fees for services rendered up to the termination date. Sections 3 (No Guarantee of Regulatory Outcomes), 4 (Intellectual Property Rights), 5 (Limitation of Liability), 6 (Confidentiality), 9 (Governing Law), and 10 (General Provisions) shall survive termination.
9. Governing Law and Jurisdiction
Scottish and UK Law:
These Terms of Service are governed by and construed in accordance with the laws of Scotland, United Kingdom. Any disputes, claims, or legal proceedings arising from or relating to these Terms, our services, or the relationship between the parties shall be subject to the exclusive jurisdiction of the Scottish courts and the courts of the United Kingdom.
Both parties irrevocably agree that the courts of Scotland and the United Kingdom shall have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with these Terms or our services, and waive any objection to such jurisdiction on the grounds of venue or forum non conveniens.
10. General Provisions
10.1 Entire Agreement
These Terms, together with any executed service agreements, Statements of Work, and confidentiality agreements, constitute the entire agreement between the parties regarding the provision of consultancy services and supersede all prior agreements, understandings, and communications, whether written or oral.
10.2 Amendments
These Terms may be amended only by written agreement signed by both parties. VigilaMed reserves the right to update these Terms from time to time, but such updates will not apply to existing engagements unless expressly agreed in writing.
10.3 Severability
If any provision of these Terms is found to be invalid, illegal, or unenforceable by a court of competent jurisdiction, the remaining provisions shall remain in full force and effect, and the invalid provision shall be modified to the minimum extent necessary to make it valid and enforceable.
10.4 Waiver
No waiver of any provision of these Terms shall be effective unless in writing and signed by the party waiving such provision. A waiver of any breach shall not constitute a waiver of any subsequent breach.
10.5 Independent Contractor
VigilaMed is an independent contractor and not an employee, agent, or partner of the client. Nothing in these Terms creates a partnership, joint venture, or agency relationship between the parties.
10.6 Force Majeure
Neither party shall be liable for any failure or delay in performance under these Terms due to circumstances beyond its reasonable control, including but not limited to acts of God, war, terrorism, pandemics, government regulations, natural disasters, or other force majeure events.
10.7 Assignment
Neither party may assign or transfer these Terms or any rights or obligations hereunder without the prior written consent of the other party, except that VigilaMed may assign these Terms to an affiliate or in connection with a merger, acquisition, or sale of assets.
10.8 Notices
All notices, requests, and communications under these Terms must be in writing and delivered to the addresses specified in the service agreement or, if no such agreement exists, to the parties' registered addresses. Notices may be delivered by email, registered mail, or courier service.
11. Contact Information
If you have questions, concerns, or requests regarding these Terms of Service, please contact us:
VigilaMed Ltd
Managing Director - Michelle Hilling
Email: Michelle.Hilling@VigilaMed.com
Address: 110-112 Buchanan Street, Glasgow, G1 2JN, United Kingdom
Registration Number: SC845807
These Terms of Service were last reviewed and updated in January 2026. By engaging with VigilaMed's services, you acknowledge that you have read, understood, and agree to be bound by these Terms.