Get Your Personalized Regulatory Newsletter

We monitor EU MDR/IVDR and FDA requirements for Medical Devices. For the EU, we track official European Commission announcements, MDCG and MEDDEV guidance, the NANDO database and national authorities communications (ANSM, BfArM). For the US, we track the Federal Register, FDA Guidance documents, Warning Letters and safety communications. Finally, we track global standards updates from ISO/IEC/CEN/CENELEC. Coverage is comprehensive and updated regularly.

Generic newsletters send the same updates to everyone. Our service is personalized to YOUR specific device type using your product codes (GMDN/EMDN). You receive only changes relevant to your device with impact assessments showing exactly how each change affects you, recommended action plans for what to do next, and pre-filled documentation templates ready for your QMS. We aim to provide actionable regulatory intelligence, not just information.

We monitor only official regulatory sources: Official Journals, government agency websites (FDA, EMA, national authorities), recognized standards organizations (ISO, CEN, CENELEC), and authorized databases (NANDO). Every regulatory change includes a direct link to the official source document so you can verify the information yourself. Our team includes QARA professionals who validate the monitoring process.

Yes, it's completely free with no credit card required. We believe regulatory intelligence should be accessible to all medical device companies. Your data is kept confidential and never shared with third parties. We offer premium features through our full-feature regulatory platform, but the core monthly intelligence newsletter report will remain free.

Setup takes less than 5 minutes. You provide your relevant product codes (GMDN for EU, EMDN for medical devices), specify your target markets (EU, US, or both), and you're done. We handle the rest, monitoring sources and preparing your personalized monthly report.

We provide the intelligence; you make the compliance decisions. Review the report to understand which regulatory changes are relevant, assess the priority level (critical/important/monitor) we've assigned, follow our recommended action plans, and integrate the pre-filled vigilance registry templates into your QMS. The final compliance decisions and QMS integration remain your responsibility.

No. This service provides the regulatory intelligence you need for vigilance, but it cannot replace your formal regulatory vigilance process. You still need to make compliance decisions, maintain your QMS documentation, and ensure ISO 13485 compliance. We make vigilance easier by providing organized, pre-analyzed intelligence with ready-to-use templates.

This service is designed for QARA professionals, regulatory affairs managers, quality managers, and medtech founders at companies working with EU and US medical device markets. It's particularly valuable for small to mid-size medtech companies that need comprehensive regulatory monitoring but don't have large regulatory teams.

You can register multiple devices and receive separate intelligence reports for each one. Each device gets its own personalized monitoring based on its specific product codes and target markets, ensuring you get relevant intelligence for your entire product portfolio.

Absolutely. Your company information, product details, and device specifications are kept strictly confidential. We never share your data with third parties. Your information is used solely to personalize your regulatory intelligence reports. You can review our privacy policy and request data deletion at any time.