Terms of Service

By accessing our website at softwarequality.guru or engaging Software Quality Guru ("Company," "we," "our," or "us") for consulting services, you ("Client") agree to be bound by these Terms of Service. If you do not agree to these terms, please do not use our website or services.

These Terms of Service apply to all visitors, users, and clients. For formal consulting engagements, a separate Statement of Work (SOW) or consulting agreement will govern the specific scope, deliverables, timeline, and fees of that engagement. In the event of a conflict, the executed consulting agreement takes precedence over these general Terms.

Software Quality Guru provides specialized consulting services for the medical device software industry, including but not limited to:

Services may be provided remotely or on-site as agreed. All engagements are subject to a separately executed Statement of Work or consulting agreement specifying deliverables, timelines, and fees.

Nature of Consulting Services

Software Quality Guru provides professional consulting advice based on our expertise and the information you provide. Our services are advisory in nature.

No Guarantee of Regulatory Approval

We do not guarantee that following our advice will result in regulatory approval, clearance, certification, or any specific regulatory outcome. Medical device regulation involves many factors beyond our control, including regulatory agency discretion, evolving guidance, and the completeness and accuracy of information you provide.

Client Responsibility

You remain solely responsible for:

Our engagement does not transfer regulatory responsibility from you to us.

Mutual Confidentiality

Both parties agree to hold in strict confidence any non-public, proprietary, or sensitive information ("Confidential Information") disclosed in connection with a consulting engagement. Neither party shall disclose the other's Confidential Information to third parties without prior written consent, except as required by law.

Client Information

Any product specifications, design documents, clinical data, business strategies, or other proprietary information you share with us will be kept strictly confidential and used solely to perform the agreed services.

Our Deliverables

Consulting deliverables we create for you are considered your Confidential Information upon delivery and payment in full.

Exceptions

Confidentiality obligations do not apply to information that: (a) is or becomes publicly known through no breach of this agreement; (b) was rightfully known to the receiving party before disclosure; (c) is independently developed without use of Confidential Information; or (d) is required to be disclosed by law or court order (with prompt written notice to the disclosing party where legally permissible).

Work Product

Upon receipt of full payment, all deliverables specifically created for your engagement (e.g., SOPs, test plans, gap assessments, submission documents) become your property. Software Quality Guru retains no rights to use or reproduce these deliverables for other clients.

Pre-Existing IP and Methodologies

We retain all rights to our pre-existing intellectual property, methodologies, frameworks, templates, tools, and know-how developed independently of your engagement. We may use anonymized, aggregated learnings from engagements to improve our services.

Website Content

All content on softwarequality.guru — including text, graphics, logos, and service descriptions — is the property of Software Quality Guru and is protected by applicable copyright and intellectual property laws. You may not reproduce, distribute, or create derivative works without our express written permission.

Pricing

Fees for consulting services are set forth in the applicable Statement of Work or engagement agreement. Website use is free of charge.

Payment Terms

Unless otherwise specified in a SOW, invoices are due within 30 days of issuance. Late payments may be subject to interest at the rate of 1.5% per month or the maximum rate permitted by law, whichever is lower.

Expenses

Reasonable out-of-pocket expenses (travel, materials) incurred in connection with your engagement will be billed separately with supporting documentation, unless otherwise agreed.

Disputes

Payment disputes must be raised in writing within 15 days of invoice receipt. Disputed amounts do not entitle you to withhold undisputed amounts.

THE WEBSITE AND SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NON-INFRINGEMENT.

We do not warrant that: (a) the website will be uninterrupted, error-free, or secure; (b) any information on the website is accurate, complete, or current; or (c) our consulting advice will achieve any particular regulatory or business outcome.

Nothing in these Terms limits any rights you may have under applicable consumer protection laws that cannot be excluded or limited by contract.

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, NEITHER SOFTWARE QUALITY GURU NOR ITS PRINCIPALS, EMPLOYEES, OR AGENTS SHALL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES ARISING OUT OF OR RELATED TO YOUR USE OF OUR WEBSITE OR SERVICES — INCLUDING BUT NOT LIMITED TO LOSS OF REVENUE, LOSS OF PROFITS, REGULATORY NON-APPROVAL, RECALL COSTS, OR PRODUCT LIABILITY — EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

OUR TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO ANY CONSULTING ENGAGEMENT SHALL NOT EXCEED THE TOTAL FEES PAID BY YOU TO US UNDER THE APPLICABLE STATEMENT OF WORK DURING THE 12 MONTHS PRECEDING THE CLAIM.

Important Note for EU/EEA Residents: Nothing in these Terms excludes or limits our liability for death or personal injury caused by our negligence, fraud or fraudulent misrepresentation, or any other liability that cannot be excluded or limited under applicable European Union or member state law, including rights you have under consumer protection laws.

You agree to indemnify, defend, and hold harmless Software Quality Guru and its principals, employees, and agents from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys' fees) arising out of or related to:

This indemnification obligation does not apply to the extent the claim arises from our gross negligence or willful misconduct.

Website Access

We may suspend or terminate your access to the website at any time, without notice, for any reason, including if we reasonably believe you have violated these Terms.

Consulting Engagements

Either party may terminate a consulting engagement upon written notice if the other party materially breaches the applicable SOW or consulting agreement and fails to cure such breach within 15 days of written notice.

Effect of Termination

Upon termination: (a) your right to use our services ceases; (b) you remain liable for fees for services rendered through the termination date; (c) confidentiality obligations survive termination; and (d) provisions that by their nature should survive (including Sections 4, 5, 7, 8, 9, 11, and 12) will survive.

Governing Law

These Terms are governed by and construed in accordance with the laws of the Commonwealth of Virginia, United States, without regard to its conflict-of-law principles.

Dispute Resolution

We encourage resolving disputes through direct negotiation. If we cannot resolve a dispute within 30 days of written notice, either party may seek resolution through binding arbitration in Virginia under the American Arbitration Association (AAA) Commercial Arbitration Rules, except that either party may seek injunctive or other equitable relief in a court of competent jurisdiction.

EU/EEA Residents — Online Dispute Resolution

If you are a consumer resident in the European Union or European Economic Area, you may also use the European Commission's Online Dispute Resolution (ODR) platform at ec.europa.eu/consumers/odr to resolve disputes relating to online services. We are not obligated to participate in ADR procedures but will consider all reasonable requests.

Class Action Waiver

To the extent permitted by applicable law, you agree that any dispute resolution proceedings will be conducted on an individual basis only and not in a class, consolidated, or representative action.

We reserve the right to update or modify these Terms at any time. We will post the revised Terms on this page with an updated "Last Revised" date. For material changes, we will provide at least 30 days' notice by posting a prominent notice on our website.

Your continued use of our website or services after any changes constitutes your acceptance of the revised Terms. If you do not agree to the revised Terms, please discontinue use of our website and services.

For active consulting engagements, changes to these general Terms do not modify the terms of your executed Statement of Work or consulting agreement.

Entire Agreement: These Terms, together with any executed Statement of Work or consulting agreement and our Privacy Policy, constitute the entire agreement between you and Software Quality Guru regarding the subject matter hereof and supersede all prior negotiations, representations, or agreements.

Severability: If any provision of these Terms is found to be unenforceable or invalid by a court of competent jurisdiction, that provision will be limited or eliminated to the minimum extent necessary, and the remaining provisions will continue in full force.

Waiver: Our failure to enforce any right or provision in these Terms will not constitute a waiver of that right or provision unless acknowledged in writing.

Assignment: You may not assign your rights or obligations under these Terms without our prior written consent. We may assign our rights and obligations in connection with a merger, acquisition, or sale of all or substantially all of our assets.

Force Majeure: Neither party shall be liable for delays or failures in performance resulting from causes beyond that party's reasonable control, including acts of God, government actions, pandemics, or internet outages.

If you have any questions about these Terms of Service, please contact us:

Software Quality Guru

Email: frank@softwarequality.guru

Website: softwarequality.guru

Location: Virginia, United States

For data protection or GDPR-related inquiries, please include "Privacy Request" in the subject line. See our Privacy Policy for full details on your rights and how to exercise them.