Terms and Conditions

Last updated: 5 May 2026

Welcome to www.mdregulatory.com (the “Website”). These Terms and Conditions (“Terms”) govern your access to and use of the Website, including the purchase of digital documentation products, consulting services, self-audit tools, and any other content or services made available through the Website (collectively, the “Services”).

By accessing the Website, creating an account, subscribing to the newsletter, or purchasing any Service, you (“User”, “you”) agree to be bound by these Terms. If you do not agree, please do not use the Website.

1. Owner and contact information

The Website is owned and operated by:

MDRegulatory – Alessandro Stella
Via Ticino 84/D
20012 Cuggiono (MI), Italy
Email: info@mdregulatory.com

For the purposes of these Terms, MDRegulatory is referred to as the “Owner”, “we”, “us”, or “our”.

2. Definitions

  • Digital Products: downloadable documentation kits, SOPs, templates, checklists and any other digital content offered for sale on the Website (e.g. ISO 13485 Kit, MDSAP Kit, EU MDR Clinical Documentation, individual SOPs).
  • Consulting Services: regulatory consulting and advisory services delivered remotely or on-site (e.g. ISO 13485 implementation, EU MDR compliance, FDA QMSR, MDSAP, gap analyses, mock audits, international registration support).
  • Self-Audit Tools: free and premium interactive tools made available on the Website.
  • Content: all text, documents, templates, software, graphics, logos, audio, video and any other material available on the Website.
  • User: any natural person or legal entity accessing or using the Website.

3. Eligibility and User accounts

The Services are intended for professional use by medical device manufacturers, regulatory professionals, consultants and related organisations. By using the Website you represent that:

  • you are at least 18 years old and have the legal capacity to enter into a binding contract;
  • if you are acting on behalf of a company or other legal entity, you have the authority to bind that entity to these Terms;
  • the information you provide during registration, checkout or any other interaction is accurate, complete and up to date.

You are responsible for maintaining the confidentiality of any credentials associated with your account and for all activities carried out through your account. You must notify us immediately at info@mdregulatory.com of any unauthorised use.

4. Description of the Services

4.1 Digital Products

Digital Products are delivered electronically as downloadable files (typically Word, Excel or PDF). After successful payment, the User receives access to download the files via a link or directly from their account.

Digital Products are licensed, not sold. See Section 8 (Licence and Intellectual Property) below.

4.2 Consulting Services

Consulting Services are provided on a project, hourly or retainer basis as agreed in a separate written engagement, quote or statement of work. Specific deliverables, timelines, fees and additional terms applicable to a Consulting engagement will be set out in that document, which will prevail over these Terms in case of conflict regarding that specific engagement.

4.3 Self-Audit Tools

Self-Audit Tools are made available either free of charge or as paid premium tools. They are provided “as is” for informational and self-assessment purposes only and do not constitute regulatory approval, certification or formal audit.

4.4 Newsletter

Users may subscribe to the newsletter to receive updates, content and offers. Subscription is voluntary and Users can unsubscribe at any time using the link provided in each email or by contacting us.

5. Orders, prices and payment

5.1 Order process

The display of Digital Products on the Website constitutes an invitation to treat, not a binding offer. A binding contract is formed only when we confirm acceptance of your order by sending an order confirmation and/or by making the Digital Product available for download.

We reserve the right to refuse or cancel any order at our discretion, including in cases of suspected fraud, unauthorised payment, error in pricing or product description, or unavailability.

5.2 Prices

All prices are displayed in Euro (€) and, unless otherwise stated, are exclusive of VAT and any applicable taxes, duties or fees, which will be added at checkout where applicable in accordance with applicable law.

For B2B transactions within the EU, valid VAT identification numbers may be required and the reverse charge mechanism may apply where applicable.

We reserve the right to change prices at any time. Price changes do not affect orders that have already been confirmed.

5.3 Payment

Payment is processed through third-party payment providers integrated with our e-commerce platform (WooCommerce). The Owner does not store full payment card details on its own servers. By submitting payment details, you authorise us and our payment providers to charge the relevant amount to your selected payment method.

5.4 Invoicing

Invoices are issued electronically in accordance with applicable Italian tax law. The User is responsible for providing accurate billing information.

6. Delivery

Digital Products are delivered electronically immediately after payment confirmation, by means of a download link or access through the User’s account. Delivery is deemed completed as soon as the file(s) are made available for download. We are not liable for failed or delayed delivery caused by incorrect contact information provided by the User, email filters, or technical issues outside our reasonable control.

Consulting Services are delivered remotely or on-site according to the terms agreed in writing for each engagement.

7. Right of withdrawal and refunds

7.1 Business customers (B2B)

The statutory right of withdrawal under EU Directive 2011/83/EU and the Italian Consumer Code applies only to consumers acting outside their trade, business, craft or profession. Where the User is a business customer, no statutory right of withdrawal applies and orders are final upon confirmation, save for any additional rights granted under these Terms.

7.2 Consumers — Digital content exception

For Users qualifying as consumers under EU law, the right of withdrawal within 14 days does not apply to digital content delivered electronically when performance has begun with the consumer’s prior express consent and acknowledgement that the right of withdrawal is thereby lost (Art. 16(m) of Directive 2011/83/EU; Art. 59 of the Italian Consumer Code).

By placing an order for a Digital Product, you expressly request that the digital content be made available to you immediately and you acknowledge that, by downloading or accessing the Digital Product, you lose the right of withdrawal.

7.3 Refund policy

Given the nature of Digital Products, we generally do not offer refunds once the file has been made available for download. However, we are committed to customer satisfaction and will consider refund requests in good faith in cases of:

  • technical defects that prevent access to or use of the file and that we are unable to resolve within a reasonable time;
  • duplicate purchases;
  • material discrepancies between the product description and the file actually delivered.

Refund requests must be submitted to info@mdregulatory.com within 3 days of purchase, with a clear explanation of the issue.

Refund or cancellation terms for Consulting Services are governed by the specific written engagement applicable to that project.

8. Licence and Intellectual Property

8.1 Ownership

All Content available on the Website, including Digital Products, templates, SOPs, tools, text, graphics, logos, trademarks and software, is owned by or licensed to the Owner and is protected by copyright, trademark and other intellectual property laws.

8.2 Licence granted to the User

Upon full payment, the Owner grants the User a non-exclusive, non-transferable, non-sublicensable, worldwide licence to use the Digital Product solely for internal business purposes within a single legal entity (the “Licensee Entity”). This licence allows the User to:

  • customise and adapt the templates and SOPs to the Licensee Entity’s internal quality management system;
  • print, copy and distribute the documents internally to employees, contractors and consultants of the Licensee Entity on a need-to-know basis;
  • submit derived versions to Notified Bodies, regulatory authorities and auditors as part of the Licensee Entity’s regulatory submissions or audits.

8.3 Restrictions

Unless expressly authorised in writing by the Owner, the User shall not:

  • resell, rent, lease, sublicense, redistribute, share or otherwise make the Digital Products available to any third party, including other legal entities within the same group;
  • publish or upload the Digital Products on any website, file-sharing platform, repository or social network;
  • use the Digital Products to provide consulting, training or documentation services to third parties as a substitute for the third party purchasing its own licence;
  • remove, alter or obscure any copyright notices, trademarks or other proprietary markings;
  • use the Digital Products for any unlawful purpose.

For consulting firms, multi-site organisations or group-wide use, please contact us to discuss a tailored licence.

8.4 Feedback

Any feedback, suggestions or ideas you provide concerning the Services may be used by the Owner without obligation to you and without any requirement of compensation.

9. Acceptable use

You agree not to:

  • use the Website in violation of any applicable law or regulation;
  • attempt to gain unauthorised access to the Website, related systems or other Users’ accounts;
  • introduce viruses, trojans, worms or any other malicious code;
  • interfere with or disrupt the integrity or performance of the Website;
  • scrape, data-mine or otherwise extract data from the Website by automated means without prior written consent;
  • misrepresent your identity or affiliation.

We reserve the right to suspend or terminate access to the Website and/or to cancel orders in case of breach of these Terms.

10. Professional disclaimer

Important. The Digital Products, Self-Audit Tools and any general information made available through the Website are provided for informational and professional reference purposes only. They are not a substitute for individualised regulatory, legal or technical advice and do not constitute regulatory certification, approval or clearance.

Compliance with applicable laws, regulations and standards (including but not limited to ISO 13485, EU MDR, FDA QMSR, MDSAP, IEC 62304 and applicable national regulations) remains the sole responsibility of the User and the Licensee Entity. The User is responsible for:

  • verifying that the documentation is appropriate and applicable to its specific products, processes and target markets;
  • customising and validating the documentation to reflect its actual operations;
  • maintaining the documentation up to date with regulatory changes after the date of purchase.

The Owner makes no representation or warranty that the use of the Digital Products will result in approval by any Notified Body, regulatory authority or auditor, or in successful completion of any certification or audit process.

Consulting Services are provided based on the information supplied by the User and on the regulatory framework in force at the time. The User remains responsible for all decisions taken based on advice received.

11. Limitation of liability

To the maximum extent permitted by applicable law, the Services and Content are provided “as is” and “as available”, without warranties of any kind, whether express or implied, including without limitation any implied warranties of merchantability, fitness for a particular purpose or non-infringement.

To the maximum extent permitted by applicable law, the Owner shall not be liable for:

  • any indirect, incidental, special, consequential or punitive damages, including loss of profits, loss of business, loss of data, loss of certification or regulatory delays;
  • any damages resulting from the User’s incorrect customisation, implementation or use of the Digital Products;
  • any damages resulting from changes in laws, regulations or standards occurring after the date of purchase or delivery of the Service;
  • any damages resulting from temporary unavailability of the Website or interruptions of the Services for technical reasons.

To the maximum extent permitted by applicable law, the Owner’s aggregate liability for any claim arising out of or relating to these Terms or the use of the Services shall not exceed the amount actually paid by the User to the Owner for the specific Service giving rise to the claim in the twelve (12) months preceding the event giving rise to the claim.

Nothing in these Terms excludes or limits the Owner’s liability for fraud, wilful misconduct, gross negligence, or for any liability that cannot be excluded or limited under applicable mandatory law.

12. Indemnification

The User agrees to indemnify, defend and hold harmless the Owner and its representatives from and against any third-party claims, liabilities, damages, losses and expenses (including reasonable legal fees) arising out of or related to: (i) the User’s breach of these Terms; (ii) the User’s misuse of the Digital Products or Services; or (iii) the User’s violation of any applicable law or third-party right.

13. Privacy and Cookies

The processing of personal data carried out through the Website is described in our Privacy Policy and Cookie Policy, which form an integral part of these Terms.

14. Third-party links and services

The Website may contain links to or integrations with third-party websites and services (e.g. payment processors, hosting providers, email service providers). The Owner is not responsible for the content, policies or practices of such third parties. Use of third-party services is governed by their respective terms.

15. Changes to the Terms and to the Services

We reserve the right to modify these Terms at any time. The updated version will be published on this page with an updated “Last updated” date. Material changes will be notified to Users where reasonably possible. Continued use of the Website after the changes take effect constitutes acceptance of the revised Terms.

We may also modify, suspend or discontinue, in whole or in part, any of the Services at any time, without prior notice and without liability, except for orders already confirmed and not yet fulfilled.

16. Force majeure

The Owner shall not be liable for any failure or delay in performance caused by events beyond its reasonable control, including but not limited to acts of God, natural disasters, war, terrorism, civil unrest, pandemics, strikes, failures of public utilities, internet or telecommunications failures, or actions of governmental authorities.

17. Severability

If any provision of these Terms is held invalid, illegal or unenforceable by a competent court, the remaining provisions shall continue in full force and effect. The invalid provision shall be replaced, where possible, by a valid provision that most closely reflects the original intent.

18. Assignment

The User may not assign or transfer any rights or obligations under these Terms without the prior written consent of the Owner. The Owner may assign these Terms in connection with a merger, acquisition or sale of assets, or by operation of law.

19. Entire agreement

These Terms, together with the Privacy Policy, the Cookie Policy and any specific written engagement for Consulting Services, constitute the entire agreement between the User and the Owner regarding the use of the Website and the Services, and supersede any prior agreement on the same subject matter.

20. Governing law and jurisdiction

These Terms are governed by and construed in accordance with the laws of Italy, without regard to its conflict of laws provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply.

Business Users: any dispute arising out of or in connection with these Terms shall be subject to the exclusive jurisdiction of the courts of Milan, Italy.

Consumer Users: where the User qualifies as a consumer under applicable mandatory law, the User retains the protection of the mandatory provisions of consumer law of the country of habitual residence, and may bring proceedings before the competent court of that country.

In accordance with Article 14 of Regulation (EU) No 524/2013, consumers residing in the EU are informed that the European Commission provides an Online Dispute Resolution (ODR) platform available at https://ec.europa.eu/consumers/odr/.

21. Contact

For any question regarding these Terms, please contact:

MDRegulatory – Alessandro Stella
Via Ticino 84/D, 20012 Cuggiono (MI), Italy
Email: info@mdregulatory.com