The first dedicated eSTAR builder

Fast, all-in-one tool for efficient and collaborative eSTAR preparation

Regby streamlines single-source authoring, file management, and navigation, so that you can curate a flawless eSTAR file faster and submit earlier.

Reduce prep time and errors to clear your device faster

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Beat the target deadline

Save the time for eSTAR compilation and review by multiple hours or days with quick and easy file attachment, navigation and editing, without the lag.

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Curate a flawless and validated eSTAR

Minimize errors by syncing key terms to a single source of truth, locking each section from accidental edits—all while Regby validates your content continuously.

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Export submission-ready eSTAR PDF with attachments

Regby exports one eSTAR PDF complete with all attachments ready for you to submit on the CDRH portal or the CBER ESG.

Features

Save time

Submit faster

In Regby, each eSTAR section self-populates without lag and does not slow down with more content or attachments—no more waiting for eSTAR to catch up to you. Directly export a submission-ready PDF file with all attachments or an XML file fully compatible with the original eSTAR PDF file.

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Stay consistent

Sync from a single source of truth

Changing the product name or the predicate halfway? With all the keywords—terms, standards, file names, etc.—in sync continuously, update your single source of truth once and see the change reflected throughout the eSTAR instantly.

Keep it organized

Manage attachment files easily

Drop and drop to upload multiple files in one go. Reorder or rename files at any time. See all files in one place and sort by file size, upload timestamp or other metadata to streamline your review workflow.

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Save the hassle

Lock individual subsections

Lock and protect individual subsections at any time from accidental edits. Skip the error-prone and repetitive steps of copying and pasting from multiple Word files to a PDF. Submit with full confidence that every page is exactly how you like it to be.

Work as a team

Collaborate and track every change

Work on the eSTAR as team. Track progress, changes and comments from each team member. Leverage the maximum synergy of your team.

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We create frictionless workflows for medtech RAs.

About

For RAs, by RAs

At Regby, our team combines hands-on submission experience and RAPS-certified domain expertise with a proven tech stack to make eSTAR submissions easier and faster. We strive to deliver a reliable eSTAR solution and to achieve a shared goal—bringing life-changing devices to patients fast.

Want to stay in the loop?

Take the first step to transform your eSTAR workflow.

© Regby. All rights reserved.

Privacy Policy

Last updated and posted on: 7 May, 2025This Privacy Policy describes how Your personal information is collected, used, and shared when You visit https://regby.io/ (hereafter “Website” or the “Site”).INTERPRETATIONThe words of which the initial letter is capitalized have meanings defined under the following conditions. The following definitions shall have the same meaning regardless of whether they appear in singular or in plural.DEFINITIONSFor the purposes of this Privacy Policy:Account means a unique account created for You to access our Service or parts of our Service.Company (referred to as either “the Company”, “We”, “Us” or “Our” in this Agreement) refers to REGBY.Cookies are small files that are placed on Your computer, mobile device or any other device by a website, containing the details of Your browsing history on that website among its many uses.Device means any device that can access the Service such as a computer, a cellphone or a digital tablet.Personal Data or Personal Information is any information that relates to an identified or identifiable individual.Service refers to the Website and its materials and content.Service Provider means any natural or legal person who processes the data on behalf of the Company. It refers to third-party companies or individuals employed by the Company to facilitate the Service, to provide the Service on behalf of the Company, to perform services related to the Service or to assist the Company in analyzing how the Service is used.Usage Data refers to data collected automatically, either generated by the use of the Service or from the Service infrastructure itself (for example, the duration of a page visit).Website or the Site refers to regby.io, accessible from https://regby.io/You means the individual accessing or using the Service, or the company, or other legal entity on behalf of which such individual is accessing or using the Service, as applicable.PERSONAL INFORMATION WE COLLECTWhen You visit the Site, we automatically collect certain information about Your device. Additionally, as You browse the Site, we collect information about the individual web pages or products that You view, what websites or search terms referred You to the Site, and information about how You interact with the Site. We refer to this automatically-collected information as “Device Information.”Device Information we collect include:- User agents (We don’t use User Agents for fingerprinting, only for counting operating systems, device types, and browsers);
- Timestamps;
- Country of the visitor;
- Language of the visitor;
- Referrers;
- UTM-parameters;
- Device dimensions;
- Time on page;
- Scrolled percentage;
- Script settings;
- Do Not Track header;
- Your full name, company name and company email, only if you choose to use the general inquiry form or book a consultation with us.
There is no requirement to provide us with any personal information if you want to use the free online information resource on our website.Your browser’s Do Not Track (DNT) headers are respected.We do NOT use cookies, web beacons, tags or pixels. IP addresses of website visitors are not tracked.When we talk about “Personal Information” in this Privacy Policy, we are talking about Device Information.HOW DO WE USE YOUR PERSONAL INFORMATION?We use the Personal Information that we collect generally to arrange for digital content delivery, and provide You with services. Additionally, the Company may use Personal Information for the following purposes:- To screen for potential risk or fraud.
- To provide and maintain our Service, including to monitor the usage of our Service.
- To manage Your Account: to manage Your registration as a user of the Service—the Personal Data You provide can give You access to different functionalities of the Service that are available to You as a registered user;
- For the performance of a contract: the development, compliance and undertaking of the purchase contract for the products, items or services You have purchased or of any other contract with Us through the Service;
- To contact You: To contact You by email, telephone calls, SMS, or other equivalent forms of electronic communication, such as a mobile application’s push notifications regarding updates or informative communications related to the functionalities, products or contracted services, including the security updates, when necessary or reasonable for their implementation.
- To provide You with news, special offers and general information about other goods, services and events which we offer that are similar to those that you have already purchased or enquired about unless You have opted not to receive such information;
- To manage Your requests: To attend and manage Your requests to Us;
- For other purposes: We may use Your information for other purposes, such as data analysis, identifying usage trends, determining the effectiveness of our promotional campaigns and to evaluate and improve our Service, products, services, marketing and your experience.We use the Device Information that we collect to help us screen for potential risk and fraud, and more generally to improve and optimize our Site (for example, by generating analytics about how our customers browse and interact with the Site, and to assess the success of our marketing and advertising campaigns).SHARING YOUR PERSONAL INFORMATIONWe share Your Personal Information with third parties to help us use Your Personal Information, as described above. We use Simple Analytics to help us understand how our customers use the Site–You can read more about how Simple Analytics uses Your Personal Information here: https://dashboard.simpleanalytics.com/no-tracking.We never sell Your Personal Data.Finally, we may also share Your Personal Information to comply with applicable laws and regulations, to respond to a subpoena, search warrant or other lawful request for information we receive, or to otherwise protect our rights.TRANSFER OF YOUR PERSONAL DATAYour information, including Personal Data, is processed at the Company’s operating offices and in any other places where the parties involved in the processing are located. It means that this information may be transferred to — and maintained on — computers located outside Your state, province, country or other governmental jurisdiction where the data protection laws may differ than those from Your jurisdiction.Your consent to this Privacy Policy followed by Your submission of such information represents Your agreement to that transfer.The Company will take all steps reasonably necessary to ensure that Your data is treated securely and in accordance with this Privacy Policy and no transfer of Your Personal Data will take place to an organization or a country unless there are adequate controls in place including the security of Your data and other personal information.YOUR RIGHTSIf You are a resident of California or the European Economic Area, You have the right to access personal information we hold about You and to ask that Your personal information be corrected, updated, or deleted. If You would like to exercise this right, please contact us through the contact information below.Additionally, if You are a resident of California or the European Economic Area, we note that we are processing Your information in order to fulfill contracts we might have with You (for example if You make an order through the Site), or otherwise to pursue our legitimate business interests listed above. Please note that Your information will be transferred outside California or the European Economic Area, including to Canada and the United States.If you are outside Canada or the United States, by using the Site or by providing Your Personal Information to us, you are consenting to having Your Personal Information transferred to and stored in Canada and/or the United States.CCPA, GDPR AND UK GDPR COMPLIANCEThe Company fully adheres to CCPA, GDPR and UK GDPR regulations by refraining from collecting any personal identifiable data from end users (that is, visitors of a customer’s website or app users). We do not place cookies, collect IP addresses, fingerprint users, or use device identifiers.The CCPA applies to personal information and defines “personal information” as “information that identifies, relates to, or could reasonably be linked with a user or their household.” The Company collects no such information from the end user.DATA RETENTIONWhen You visit the Site and use Our Service, we will maintain Your Personal Information for our records for as long as necessary to provide the Services, or as permitted / required by applicable law, or until You ask us to delete this information.DISCLOSURE OF YOUR PERSONAL DATALaw enforcementUnder certain circumstances, the Company may be required to disclose Your Personal Data if required to do so by law or in response to valid and reasonably necessary requests by public authorities (e.g. a court or a government agency).Other legal requirementsThe Company may disclose Your Personal Data in the good faith belief that such action is reasonably necessary to:
-Comply with a legal obligation
-Protect and defend the rights or property of the Company
-Prevent or investigate possible wrongdoing in connection with the Service
-Protect the personal safety of Users of the Service or the public
-Protect against legal liability
SECURITY OF YOUR PERSONAL DATAThe security of Your Personal Data is important to Us, but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While We strive to use commercially acceptable means to protect Your Personal Data, We cannot guarantee its absolute security.MINORSThe Site is not intended for individuals under the age of 13, and Our Service does not address anyone under the age of 13.We do not knowingly collect personally identifiable information from anyone under the age of 13. If You are a parent or guardian, and You are aware that Your child has provided Us with Personal Data, please contact Us. If We become aware that We have collected Personal Data from anyone under the age of 13 without verification of parental consent, We take steps to remove that information from Our records.If We need to rely on consent as a legal basis for processing Your information and Your country requires consent from a parent, We may require Your parent’s consent before We collect and use that information.CHANGESWe may update this privacy policy from time to time in order to reflect, for example, changes to our practices or for other operational, legal or regulatory reasons. We regularly review this Privacy Policy and make sure that we process your information in ways that comply with it.You are advised to review this Privacy Policy periodically for any changes and refer to the “Last updated and posted on” date at the top of this Privacy Policy. Changes to this Privacy Policy are effective when they are posted on this page.CONTACT USFor more information about our privacy practices, if You have questions, or if You would like to make a complaint or suggestion, please contact us on LinkedIn.

© Regby. All rights reserved.

What is Regby?

Regby is an all-in-one eSTAR builder tool that enables you to create submission-ready eSTAR files from scratch without the need for Acrobat Pro or Foxit. Every step of the workflow including editing, review and file attachment can be done using Regby.

© Regby. All rights reserved.

What types of submissions are supported?

Currently, only the pre-submission and the nIVD 510(k) are supported. Please let us know which other submissions you would like to make using Regby. You may book a time to speak with us directly or message us through our LinkedIn page.

© Regby. All rights reserved.

Is Regby available offline?

Regby may only be accessed online. However, exporting your content as XML or PDF for offline use with Acrobat Pro or Foxit is available.

© Regby. All rights reserved.

Is my data secure with Regby?

At Regby, security is our priority. We ensure that industry best practices are followed and operational controls are in place to safeguard your invaluable data.

© Regby. All rights reserved.

Do you use customer data to train AI?

No. At Regby, we take data privacy seriously and will process your data only for the purposes to which you have explicitly consented.

© Regby. All rights reserved.

Is Regby for me?

Regby is designed for the demanding needs of medtech manufacturers. It combines thee strengths of the original eSTAR form with the familiar features of Google Doc as well as enhancements unique to Regby while delivering state-of-the-art reliability.

© Regby. All rights reserved.