The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746.
This element will be key for the traceability of devices in Europe.
Smarteye – Full QMS Built for MedTech
Smarteye is a modular Quality Management System (QMS) built specifically for life sciences and medical devices, including hardware, software (SaMD), and combination products. It goes far beyond just document control.
Key Features:
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Document control with electronic signatures (21 CFR Part 11 compliant)
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Complete CAPA lifecycle with root cause analysis and effectiveness checks
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Internal/external audit tracking and follow-up
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Training management with auto-assignment and completion tracking
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Risk dashboard, management review data, and KPI reporting
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Integrates with Microsoft Office, and design control modules
Why it’s valuable:
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Smarteye doesn’t just digitize your QMS—it makes it smarter. Whether you’re scaling or optimizing, it provides everything from basic compliance to executive dashboards. It’s especially useful for companies that want to avoid siloed systems and keep everything traceable—from design inputs to final release.
EasyIFU – Label and eIFU Management Made Effortless
EasyIFU is a cloud-based platform for managing medical device labels and electronic Instructions for Use (eIFUs)—built to keep you fully compliant with the latest EU Regulation (EU) 2025/1234.
This regulation replaces 2021/2226 and sets stricter requirements for eIFUs: they must be always available, up to date, and easily accessible to users, professionals, and authorities.
EasyIFU delivers exactly that.
What It Solves in 2025
If you’re a manufacturer, here’s what you’re probably dealing with:
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You need to reduce IFU printing and translation costs.
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You’re struggling to keep your IFUs traceable and current.
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You need to comply with MDR and 2025/1234, but lack technical infrastructure.
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You want users to access IFUs via QR code, 24/7, even in multilingual formats.
EasyIFU solves all of this—without needing a developer or custom IT setup.
Key Features
- Regulation (EU) 2025/1234 Compliant : Ensures your eIFUs meet new requirements for accessibility, traceability, and language support under the latest EU regulation.
- Free Tier Available : Start creating and publishing your first eIFUs with no cost. Ideal for startups, pilot projects, or testing the system before scaling.
- Smart Label Generator : Answer guided regulatory questions, and the platform automatically builds a compliant label with:
- UDI data
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Country-specific content
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MDR symbols (EN ISO 15223-1)
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Language packs
- Structured Review & Approval Workflow : Each label or IFU goes through a creator → approver → releaser chain. Everything is time-stamped and audit-ready.
- QR Code + Permanent Link : Once released, your IFU is published online and linked to a unique QR code that you can print on the packaging. No website maintenance required.
- Version Control + Archiving : Every document change is tracked. If you update your IFU, users always get the latest version, and auditors can access the full history.
- Multilingual & Multi-product Support : One platform for all your devices, languages, and user types.
Evidence – Next-Level Risk Management for MDR
Evidence is a cutting-edge, AI-powered platform designed specifically for automating and optimizing clinical literature reviews for medical device submissions. Whether you’re working on a Clinical Evaluation Report (CER), PMCF plan, or preparing for a Notified Body review, Evidence ensures your work is traceable, compliant, and lightning-fast—with no specialized expertise required.
This platform isn’t a generic document tool—it’s your smart assistant for turning literature strategy into a regulatory asset.
Why It Matters:
In 2025, manufacturers are under pressure to:
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Conduct and document literature searches in a repeatable, reproducible way
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Align every decision with Notified Body expectations
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Save time while reducing errors
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Show complete transparency in clinical evidence generation
Evidence does all this for you—automatically.
Key Features:
- One-Click Search Metadata Import : Every filter, search parameter, and decision is tracked in the background. You never have to manually copy-paste search queries or screenshots again.
- Built-In Best Practices : Not sure how to structure your review for EU MDR or FDA submissions? Evidence includes pre-configured regulatory workflows so you’re guided every step of the way—with confidence.
- AI Text Analysis : Let AI pre-screen articles, extract key information, and highlight relevant content—saving hours of manual review and increasing consistency.
- Automated Literature Protocol Generation: As you work, Evidence records your actions and decisions—then generates a submission-ready protocol with one click. No formatting. No guessing. Just results.
- Simplified Review Management: Track your screening progress at a glance, filter documents easily, and manage review stages across your team. Clear, collaborative, and organized.
- Expert-level Compliance Without the Expert
Designed to meet the standards and scrutiny of MDR Notified Bodies—without needing an in-house literature spet.
Regulatory Globe
In the case, you need to perform some Gap Assessment or need specific templates required for Medical Device companies. Regulatory Globe is building them for you.
The idea of Mickael Galiker, the CEO of Regulatory Globe, is to help medical device manufacturers to save time. This started with the EU MDR 2017/745 regulation when a gap assessment was needed to identify what are the actions a company should perform to be compliant with the new regulation.
Then this evolved to other standards and other requirements. These are essentially Excel documents that are completely built and which contains all the requirements you need to follow to be compliant.
As of today, you will find these templates available:
- Gap assessment EU MDR
- Gap assessment EU IVDR
- many others on the website
So if you are really trying to identify the gaps in your quality and regulatory affairs department, you need this tool.
EUDAMED Software Service
This platform helps you prepare and submit structured data to the European Commission’s EUDAMED database for medical devices, including Actor Registration, UDI, Device, Clinical, and Vigilance modules.
Key Features:
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Automated XML generation for all EUDAMED modules
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Built-in validation to catch errors before submission
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Role-based access for multiple team members and economic operators
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Dashboard to manage submission status, rejections, and compliance timelines
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Ideal for manufacturers, ARs, and importers
Why it’s valuable:
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EUDAMED is complex—and mandatory. This tool is for teams that don’t want to spend hours coding XML or guessing how to submit data correctly. It reduces errors, rejections, and time to compliance.
MedBoard
This platform is available on the internet and will save you a lot of time if you need Regulatory Information.
When I was looking for the new Medical Device Regulation EU MDR 2017/745, I was as everyone heading to the EUROPA website where the regulation is available as PDF or Web text. But this was really plain text without explanation.
When Ivan Perez Chamorro, CEO of Medboardco.com contacted me. I was really skeptical about his tool. But after a few months of testing it, I cannot do any search without going to the platform.
The idea of Ivan is to help companies to save time finding Regulatory and Medical Devices information in a very simple, efficient, and visual way, with a vast collection of content in the platform and driven by their search engine and algorithm. Regarding visuals, they put some visual explanation of the regulation text in the EU MDR and IVDR. For example, when you read a chapter, an infographic is attached to help you understand the concept.
If you are reading some regulations, you see that they are linking to some other chapters or regulations. On Medboardco.com, there is a link available where you can directly access the information. No need to scroll anymore.
Meddevo.com
The promise of Meddevo is to digitalize your QA RA department by providing you the right tool for your Medical Device company. They will introduce to you the concept of eTD or Electronic Technical Documentation.
Imagine a tool that is really knowing all the regulatory requirements. And which alerts you when something is missing. This is really a dream tool.
The idea of Michael Kania, CEO of Meddevo, is to provide to any QA RA department an assistant to help them save time. This would be ideal for small companies that don’t have a lot of resources and really need to focus on what is most important.
Meddevo.com is designed specifically to fit the Medical Device requirements so don’t use it if you are a cosmetic or pharmaceutical company.
We always see some general tools and complain because they are not really understanding our business. Or, we need to buy different tools for different actions (Document control, training, complaints, CAPA, Audit…). With Meddevo, this is not needed anymore.
This tool has also an audit mode, which verifies if you have everything or if after an update something is missing.
If you are still using paper for your documents, or if you are using many tools that are not communicating together, I encourage you to test this tool and check if this can help you on your journey to put a compliant medical device on the market.
Work Smarter, Not Just Harder
In today’s regulatory landscape, manual tools are a liability. You don’t just need digital systems—you need the right platforms:
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Purpose-built for medical devices
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Scalable, traceable, and audit-ready
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Aligned with evolving regulations
If your team is still struggling with disconnected Excel sheets, email chains, and Word documents, it’s time to modernize your compliance strategy.
Let these tools handle the complexity—so you can focus on quality, safety, and performance.
About the Author: Monir El Azzouzi
