1. Services Provided
MD Regulatory Consulting Inc., operating as MD Regulatory Strategy, provides strategic regulatory consulting services for medical device companies including:
(I) Regulatory strategy advisory for FDA and EU MDR pathways.
(II) Fractional director-level regulatory oversight.
(III) Submission readiness and quality review (peer review).
(IV) Cross-jurisdictional regulatory strategy alignment.
(V) Regulatory diligence for transactions and investments.
(VI) Change control risk assessment and evaluation.
(VII) Email and SMS communications (optional) related to your service requests.
Our services are designed to help leadership teams make defensible regulatory decisions across FDA, EU MDR, and international regulatory frameworks through strategic advisory support.
2. Nature of Advisory Services
2.1 Strategic Advisory Only
All services provided by MD Regulatory Strategy are strategic and advisory in nature. Our services include regulatory strategy guidance, risk identification, quality review, and director-level oversight. Services do NOT include:
(I) Hands-on regulatory execution or document authorship.
(II) Submission ownership or regulatory authority point of contact responsibilities.
(III) Legal advice or legal representation.
(IV) Clinical advice or medical guidance.
(III) Regulatory authority determinations or approvals.
(IV) Guarantees of specific regulatory outcomes or timelines.
2.2 Client Responsibilities
Clients retain full responsibility for:
(I) All regulatory submissions and direct communications with regulatory authorities.
(II) Final regulatory decisions, pathway selections, and compliance obligations.
(III) Implementation and execution of recommended strategies.
(IV) Maintaining regulatory authority as the designated point of contact with FDA, Notified Bodies, or other regulators.
(V) Document authorship, submission ownership, and regulatory compliance.
2.3 No Guarantees
MD Regulatory Strategy does not guarantee regulatory outcomes, approvals, clearances, or specific timelines. Regulatory decisions are made by regulatory authorities based on their independent review and assessment.
3. SMS/Text Messaging Terms and Consent (Optional)
3.1 Opt-In and Consent
Providing your mobile phone number is entirely optional. If you choose to provide your phone number and opt into SMS communications, you expressly consent to receive text messages from MD Regulatory Strategy at the phone number you provided. These messages may include:
(I) Consultation appointment confirmations and reminders.
(II) Booking confirmations and rescheduling notifications.
(III) Engagement updates and milestone notifications.
(IV) Time-sensitive regulatory alerts relevant to your engagement.
(V) Project deliverable notifications.
(VI) Administrative messages related to your account.
Your consent to SMS communications is not a condition of service. You may use our services and receive all essential communications via email without providing a phone number or opting into SMS.
3.2 Message Frequency
Message frequency varies depending on your engagement with our services. During active consulting engagements, you may receive:
(I) Consultation-related messages: Up to 2-3 messages per scheduled consultation.
(II) Engagement updates: Up to 2-5 messages per month during active projects.
(III) Administrative notifications: As needed for urgent matters.
3.3 Opt-Out Instructions
You may opt out of SMS communications at any time by:
(I) Replying STOP to any text message from MD Regulatory Strategy.
(II) Contacting us at [email protected].
(III) Notifying us during any consultation or communication.
After opting out, you will receive one final confirmation message, and then no further messages will be sent unless
you re-opt-in.
3.4 Help and Support
For SMS support, reply HELP to any message or contact us at [email protected].
3.5 Message and Data Rates
Standard message and data rates may apply based on your mobile carrier's plan. MD Regulatory Strategy is not responsible for any charges incurred from your mobile carrier.
3.6 Supported Carriers
Our SMS service is available on all major U.S. carriers including AT&T, Verizon, T-Mobile, and other participating carriers. Service availability may vary by carrier.
4. Compliance with A2P 10DLC Regulations
MD Regulatory Strategy fully complies with the Application-to-Person (A2P) 10 Digit Long Code (10DLC) regulations established by mobile carriers and regulatory authorities. Our SMS messaging practices adhere to:
(I) TCPA (Telephone Consumer Protection Act) requirements.
(II) CTIA Messaging Principles and Best Practices.
(III) Carrier-specific A2P 10DLC guidelines.
(IV) CAN-SPAM Act for commercial messaging.
We ensure that:
(I) All SMS communications require explicit opt-in consent.
(II) Message content is relevant to your service requests and engagements.
(III) Opt-out mechanisms are clearly provided and honored immediately.
(IV) Messaging frequency is transparent and controlled.
(V) No messages are sent using auto-dialers without prior express written consent.
(VI) No prohibited content (SHAFT: Sex, Hate, Alcohol, Firearms, Tobacco) is included.
5. Email Communications
5.1 Marketing and Informational Emails
By subscribing to our email list or providing your email address with marketing consent, you may receive:
(I) Regulatory insights and industry updates.
(II) Best practices and thought leadership content.
(III) Service announcements and new offerings.
(IV) Educational resources and guidance.
5.2 Transactional Emails
You will receive transactional emails related to your services including:
(I) Consultation booking confirmations.
(II) Appointment reminders.
(III) Engagement updates and deliverables.
(IV) Payment receipts and invoices.
(V) Account notifications.
(VI) Project milestone communications.
These transactional emails cannot be opted out of as they are essential to service delivery.
5.3 Email Opt-Out
You may unsubscribe from marketing emails at any time by:
(I) Clicking the "unsubscribe" link in any email.
(II) Contacting [email protected].
(III) Updating your email preferences.
6. Privacy and Data Protection
6.1 Information We Collect
We collect personal and business information that you voluntarily provide when you:
(I) Request a consultation or engage our services.
(II) Subscribe to our communications.
(III) Opt into SMS communications (optional).
(IV) Contact us with inquiries.
This may include your name, email address, phone number (optional), company information, job title, payment information, and any regulatory or business details you provide during consultations or engagements.
6.2 How We Use Your Information
Your information is used solely to:
(I) Deliver the advisory services you've requested.
(II) Send consultation reminders and confirmations.
(III) Provide strategic guidance and deliverables.
(IV) Process payments and invoices.
(V) Send communications you've opted into.
(VI) Improve our services.
(VII) Comply with legal obligations.
6.3 Confidentiality
All information shared during consulting engagements is treated as strictly confidential in accordance with professional consulting standards. We do not share your confidential business information with third parties without your explicit consent, except as required by law.
6.4 Data Sharing
We do not sell, rent, or share your personal information with third parties for marketing purposes. Your information
may be shared only with:
(I) Service providers necessary for service delivery (payment processors, scheduling platforms, email/SMS service providers, cloud storage).
(II) Legal authorities if required by law.
All service providers are bound by confidentiality agreements.
6.5 Data Security
We implement appropriate technical and organizational security measures to protect your personal and business data against unauthorized access, alteration, disclosure, or destruction.
6.6 Data Retention
We retain your personal and engagement information as long as necessary to provide services and comply with legal and professional obligations. You may request deletion of your data by contacting
[email protected], subject to legal retention requirements.
7. Consultation Booking and Cancellation Policy
7.1 Booking
Consultations can be requested through our contact form or by emailing [email protected]. You will receive confirmation via email and, if you've opted in, via SMS.
7.2 Cancellation and Rescheduling
(I) Cancellations or rescheduling requests should be made at least 24 hours before your scheduled consultation.
(II) Late cancellations (within 24 hours) may be subject to a cancellation fee depending on the engagement terms. (III) To cancel or reschedule, reply to your confirmation email/SMS or contact [email protected].
7.3 No-Show Policy
Failure to attend a scheduled consultation without prior notice may result in forfeiture of the session time and associated fees.
8. Engagement Terms and Agreements
8.1 Scope of Work
Each consulting engagement will be documented through an engagement letter, statement of work, or similar
agreement specifying:
(I) Scope of services and deliverables.
(II) Timeline and milestones.
(III) Fees and payment terms.
(IV) Confidentiality obligations.
(V) Intellectual property rights.
8.2 Engagement Types
MD Regulatory Strategy offers multiple engagement models:
(I) Snapshot Assessments: Focused regulatory assessments typically completed within 1-3 weeks.
(II) Fractional Engagements: Ongoing director-level oversight on a part-time basis.
(III) Retainer Engagements: Continuous strategic advisory support over defined periods.
(IV) Project-Based Engagements: Specific deliverables with defined scope and timeline.
8.3 Modification of Scope
Any changes to the agreed scope of work must be documented in writing and mutually agreed upon by both parties.
9. Professional Standards and Use of Technology
9.1 Professional Expertise
MD Regulatory Strategy maintains professional standards appropriate for regulatory consulting services. Our principals have extensive experience in FDA, EU MDR, and international regulatory frameworks.
9.2 Use of Analytical Tools
MD Regulatory Strategy may utilize analytical tools, structured evaluation frameworks, and decision-support technologies to assist with research, synthesis, and strategic analysis. All professional judgments, regulatory interpretations, and client-facing deliverables are independently reviewed and finalized by a qualified regulatory professional before delivery.
9.3 Quality Assurance
We maintain quality assurance processes to ensure deliverables meet professional consulting standards and accurately reflect regulatory precedent and best practices.
10. Health and Safety Disclaimer
10.1 Not Medical Devices
MD Regulatory Strategy provides consulting services for medical device companies but does not design, manufacture, or distribute medical devices. We are not responsible for the safety or efficacy of your products.
10.2 Regulatory Compliance Responsibility
Clients are solely responsible for ensuring their products and practices comply with applicable regulatory requirements. Our advisory services support your decision-making but do not replace your regulatory obligations.
10.3 Emergency Situations
If you become aware of serious adverse events, safety concerns, or regulatory violations related to your products, you must immediately report them to the appropriate regulatory authorities and take corrective actions as
required by law.
11. Payment Terms
11.1 Fees
Fees for services are outlined in the engagement agreement or statement of work. Payment terms may include:
(I) Hourly rates for time-based services.
(II) Fixed fees for snapshot assessments or defined projects.
(III) Monthly retainers for ongoing advisory support.
(IV) Fractional arrangements based on allocated time commitments.
11.2 Payment Methods
We accept major credit cards, ACH transfers, wire transfers, and other payment methods as agreed upon during engagement setup.
11.3 Invoicing
Invoices are issued according to the payment schedule outlined in your engagement agreement. Payment is due within the timeframe specified on the invoice (typically 15-30 days).
11.4 Late Payment
Late payments may be subject to interest charges at the rate of 1.5% per month (or the maximum rate permitted by law, whichever is lower).
11.5 Refund Policy
Refunds are evaluated on a case-by-case basis. If you are dissatisfied with our services, please contact [email protected] within 15 days of receiving deliverables to discuss resolution options.
12. Intellectual Property
12.1 Client Intellectual Property
All proprietary information, regulatory strategies, product data, and confidential business information provided by you remains your intellectual property. We claim no ownership rights to your confidential information.
12.2 MD Regulatory Strategy Intellectual Property
Our methodologies, frameworks, templates, assessment tools, and proprietary processes remain the intellectual property of MD Regulatory Strategy. Clients receive a limited license to use deliverables for their internal business purposes only.
12.3 Work Product
Deliverables created specifically for your engagement (e.g., regulatory strategy reports, assessment documents) become your property upon full payment, subject to our retention of rights to use de-identified information for methodology improvement and case study purposes (with your permission).
12.4 Restrictions
You may not reproduce, distribute, sublicense, or create derivative works from our proprietary methodologies or frameworks without our express written permission.
13. Limitation of Liability
13.1 No Consequential Damages
To the fullest extent permitted by law, MD Regulatory Strategy, its principals, contractors, and affiliates shall not be liable for any indirect, incidental, consequential, special, or punitive damages arising from your use of our services, including but not limited to:
(I) Regulatory delays or denials.
(II) Lost revenue or business opportunities.
(III) Costs of regulatory submissions or additional studies.
(IV) Reputational harm.
(V) Regulatory enforcement actions.
13.2 Advisory Nature
MD Regulatory Strategy provides strategic advisory services only. We are not responsible for regulatory decisions, outcomes, or actions taken by you or by regulatory authorities.
13.3 Reasonable Efforts
While we make reasonable efforts to provide accurate and defensible regulatory guidance, we cannot guarantee specific outcomes or predict regulatory authority actions with absolute certainty.
14. Indemnification
You agree to indemnify, defend, and hold harmless MD Regulatory Strategy, its principals, employees, and contractors from any claims, damages, losses, liabilities, and expenses (including reasonable attorneys' fees) arising from:
(I) Your use of our advisory services.
(II) Your products, regulatory submissions, or business operations.
(III) Your breach of these Terms and Conditions.
(IV) Your violation of any laws or regulations.
15. Termination
15.1 Termination by Either Party
Either party may terminate the engagement with written notice in accordance with the terms specified in the engagement agreement. Typical notice periods range from 15-30 days.
15.2 Effect of Termination
Upon termination:
(I) You remain obligated to pay for all services rendered through the termination date.
(II) Confidentiality obligations survive termination indefinitely.
(III) Intellectual property rights and limitations of liability survive termination.
(IV) We will deliver any completed work products upon receipt of final payment.
15.3 Immediate Termination
We reserve the right to terminate services immediately if:
(I) You breach material terms of the engagement agreement.
(II) Payment obligations are not met.
(III) You request services that violate ethical or legal standards.
(IV) The engagement creates conflicts of interest that cannot be resolved.
16. Confidentiality and Non-Disclosure
16.1 Mutual Confidentiality
Both parties agree to maintain the confidentiality of proprietary and confidential information shared during the engagement.
16.2 Permitted Disclosures
Confidential information may be disclosed only:
(I) With the disclosing party's written consent.
(II) To employees, contractors, or service providers who need to know (under confidentiality obligations).
(III) As required by law, court order, or regulatory requirement.
16.3 Non-Disclosure Agreements
For engagements involving highly sensitive information, we are willing to execute separate mutual non-disclosure agreements (NDAs).
17. Dispute Resolution
17.1 Good Faith Negotiation
In the event of any dispute arising from these Terms and Conditions or our services, the parties agree to first attempt resolution through good faith negotiation.
17.2 Mediation
If negotiation fails to resolve the dispute within 30 days, the parties agree to attempt mediation before a mutually agreed-upon mediator.
17.3 Arbitration
If mediation is unsuccessful, disputes shall be resolved through binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association. Arbitration shall take place in Wisconsin, United States.
17.4 Exceptions
Either party may seek injunctive relief in court to protect intellectual property rights or confidential information without first pursuing mediation or arbitration.
18. Changes to Terms
We may update these Terms and Conditions from time to time to reflect changes in our practices, services, or legal requirements. Any changes will be posted on our website, and your continued use of our services signifies your acceptance of any such changes. For material changes affecting SMS communications or payment terms, we will notify you via email or text message (if opted in).
19. Governing Law and Jurisdiction
These Terms and Conditions are governed by the laws of the State of Wisconsin, United States, without regard to its conflict of law provisions. Any legal action or proceeding related to these terms shall be brought exclusively in the state or federal courts located in Wisconsin.
20. Severability
If any provision of these Terms and Conditions is found to be invalid, illegal, or unenforceable, the remaining provisions shall continue in full force and effect.
21. Entire Agreement
These Terms and Conditions, together with any engagement agreement, statement of work, and our Privacy Policy, constitute the entire agreement between you and MD Regulatory Strategy regarding our services and supersede
all prior agreements and understandings.
22. Contact Information
If you have any questions or concerns regarding these Terms and Conditions, our services, or communications practices, please contact us:
MD Regulatory Strategy MD Regulatory Consulting Inc.
Email: [email protected]
For SMS Support: Reply HELP to any message or email [email protected].
For Customer Service and General Inquiries: Email: [email protected]
Business Address: N7167 1280th St. River Falls, Wisconsin 54022 United States
23. Acknowledgment
By using MD Regulatory Strategy services, requesting a consultation, engaging our services, opting into communications, or providing your contact information, you acknowledge that you have read, understood, and agree to be bound by these Terms and Conditions.