Terms of Service
By using the services offered by Rosmir Consulting LLC, you agree to the following terms and conditions.
1. Scope of Service
Rosmir Consulting LLC provides professional technology consulting services, with a focus on digital transformation and cybersecurity readiness.
We offer specialized advisory services for organizations developing medical devices and healthcare-related software, particularly in the areas of product security and regulatory preparedness. Our goal is to help clients navigate evolving cybersecurity requirements and align their development practices with recognized industry and regulatory standards.
These include, but are not limited to:
- FDA Guidance on Cybersecurity in Medical Devices
- Health Canada pre- and post-market cybersecurity requirements
- EU MDR and IVDR cybersecurity expectations
- ISO 13485 (Quality Management Systems for Medical Devices)
- IEC 62304 (Medical Device Software Lifecycle)
- ISO/IEC 27001 (Information Security Management)
- IMDRF Cybersecurity Principles
We support clients in both U.S. and international markets, integrating cybersecurity and compliance planning into all phases of the product development lifecycle—from initial design through post-market support.
Rosmir Consulting LLC does not manufacture, distribute, or sell medical devices, nor do we make any claims regarding product safety, effectiveness, or regulatory approval. Our services are strictly consultative in nature, and clients remain solely responsible for meeting any legal or regulatory requirements in their respective jurisdictions.
2. Disclaimer of Warranty
All services provided by Rosmir Consulting LLC are offered on an "as-is" and "as-available" basis, without any warranties, guarantees, or representations of any kind—express or implied.
While we aim to provide accurate, timely, and industry-aligned consulting services, Rosmir Consulting LLC does not guarantee that any recommendations or deliverables will result in regulatory approval, compliance certification, or acceptance by any government or regulatory authority, including but not limited to the FDA, Health Canada, the European Medicines Agency (EMA), or similar bodies.
Rosmir Consulting LLC does not develop, distribute, or sell medical devices or regulated products, and we do not make any claims about the clinical performance, safety, or efficacy of client technologies. Clients are solely responsible for verifying and obtaining any regulatory, legal, or compliance approvals required for their products or services.
Use of our consulting services is at your own discretion and risk.
3. Confidentiality
We respect and protect the confidentiality of all client information shared during engagements. Rosmir Consulting LLC will not disclose client information to third parties without prior written consent, unless legally required to do so.
4. Limitation of Liability
To the fullest extent permitted by applicable law, Rosmir Consulting LLC shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising out of or relating to the use of our services, including but not limited to lost profits, regulatory delays, or reputational harm.
Our total liability, whether in contract, tort, or otherwise, shall be limited to the total amount paid by the client for services rendered within the previous 3 months.
5. Export Compliance
Rosmir Consulting LLC complies with U.S. export control laws and regulations. We do not provide services to individuals or entities located in or associated with countries subject to comprehensive U.S. sanctions, including but not limited to Iran, North Korea, Cuba, Syria, and regions subject to OFAC restrictions.
Clients are responsible for ensuring that they are authorized to receive services under applicable export laws.
6. Governing Law
These Terms of Service shall be governed and interpreted under the laws of the State of Maryland, United States, without regard to its conflict of laws principles. Any disputes shall be resolved in the courts of Maryland.
7. Promotions and Offers
If Rosmir Consulting LLC offers promotional services (e.g., free consultations, introductory pricing), the specific terms, eligibility, and expiration dates of such offers will be clearly stated on the website or promotional materials. Promotions are subject to change or cancellation at any time without notice.
For questions regarding these terms, please contact us at support@rosmir.com.