Terms and Conditions
Terms and Conditions
Welcome to MDRCert ("we," "our," or "us"). These Terms and Conditions govern your use of our website (https://mdrcert.com) and your engagement with our medical device regulatory consulting services (collectively, the "Services").
By accessing our website or using our Services, you agree to be bound by these Terms and Conditions. If you do not agree with any part of these terms, please do not use our website or Services.
Services Provided
MDRCert specializes in regulatory compliance consulting for the medical device and in vitro diagnostic industries. Our Services include, but are not limited to, EU MDR/IVDR strategy, QMS implementation (ISO 13485), risk management (ISO 14971), clinical evaluation documentation, PMCF, and registration strategy services. The exact scope of Services will always be defined in detail in a separate proposal, contract, or Statement of Work (SOW) agreed upon by both parties.
No Guarantee of Regulatory Approval
While MDRCert provides expert guidance based on current regulatory requirements and global best practices, we do not and cannot guarantee the approval, clearance, or certification of any medical device or quality management system by Notified Bodies, Competent Authorities, or other regulatory agencies. The final responsibility for regulatory compliance, product safety, and market placement rests solely with the legal manufacturer of the device.
Automatically Collected Data
We understand the highly sensitive and proprietary nature of medical device documentation, product designs, and business strategies. MDRCert is committed to maintaining strict confidentiality. We will not disclose your proprietary information, technical files, or trade secrets to any third party without your prior written consent, except where strictly required by law. Mutual Non-Disclosure Agreements (NDAs) are typically executed prior to the commencement of any consulting work.
Intellectual Property
All website content, reports, templates, workflows, and training materials provided by MDRCert during the delivery of our Services remain the intellectual property of MDRCert unless explicitly transferred in writing via a contract. You are granted a non-exclusive, non-transferable license to use these materials solely for the internal compliance purposes of your organization. You may not resell, distribute, or repackage our proprietary consulting materials.
Client Responsibilities
To ensure the successful and timely delivery of our Services, you agree to:
- Provide timely, complete, and accurate information, historical data, and documentation required for our consulting workflows.
- Make key personnel (e.g., engineers, clinical specialists) available for discussions, audits, and reviews as reasonably requested.
- Ensure that any data or materials provided to us do not infringe on the intellectual property rights of third parties.
Limitation of Liability
To the maximum extent permitted by applicable law, MDRCert and its consultants, directors, partners, and employees shall not be liable for any indirect, incidental, special, consequential, or punitive damages, including without limitation, loss of profits, data, use, goodwill, or other intangible losses, resulting from:
- Your access to or use of (or inability to access or use) the Services;
- Any binding or non-binding decisions made by regulatory bodies (e.g., Notified Bodies, FDA, Competent Authorities) regarding your devices;
- Delays in product launches, sales, or certification due to regulatory changes, audit findings, or processing times by external authorities.
Our total aggregate liability for any claim arising out of or relating to these Terms or the Services shall not exceed the total amount paid by you to MDRCert for the specific consulting service giving rise to the claim in the twelve (12) months preceding the claim.
Fees and Payment Terms
Fees for our consulting Services will be outlined in a mutually agreed Proposal, Quote, or SOW. Unless otherwise specified in writing, invoices are payable within 30 days of the invoice date. MDRCert reserves the right to suspend Services or withhold final deliverables if payments are not received in a timely manner.
Changes to These Terms
We reserve the right, at our sole discretion, to modify or replace these Terms and Conditions at any time. We will provide notice of any significant changes by posting the new Terms on our website and updating the "Last Updated" date. Your continued use of the website or Services after any changes constitutes your acceptance of the new Terms.
Contact Us
If you have any questions about these Terms and Conditions, please contact us at:
- Email: [email protected]
- Phone: +382 68 682 766
- Website: https://mdrcert.com/contact-us/
