Simplify your regulatory monitoring with AI.
Continuous and personalized regulatory monitoring for Digital Medical Devices.
.png)
Digital Medical Device regulations are constantly evolving.
Staying up to date with MDR 2017/745, IVDR 2017/746, ISO standards, and authority decisions is essential, but it takes too much time and requires dedicated expertise.
It is mandatory for the Person Responsible for Regulatory Compliance (PRRC), who must maintain structured and specific monitoring to anticipate changes impacting CE marking and market maintenance.
SYNCHRO
SYNCHRO organizes regulatory monitoring on digital medical devices for you, by filtering useful information through AI and expert human selection. You gain in clarity, speed, and relevance of information.
Reliable, personalized, and immediately actionable technical monitoring.
AI monitoring designed for Startups and MedTech in digital health.
Five concrete benefits to turn regulatory monitoring into an anticipation lever.
Intelligent automation
Our AI continuously analyzes official publications, standards, decisions, and relevant updates without any action on your part.
Verified & reliable sources
Unlike generic information feeds, each source is selected and sorted for its regulatory relevance.
Personalized compliance
Receive only the alerts you need: MDR 2017/745, IVDR 2017/746, ISO 13485, IEC 62304, CE requirements, Notified Body positions, AI Act, changes directly impacting your compliance.
Time savings & clarity
You avoid document overload and time wasted on manual searches.
Proactive monitoring
Our AI helps medical device stakeholders anticipate regulatory changes rather than react to them. You are alerted as soon as a change becomes relevant.
Two plans tailored to your needs.
From reliable generalist monitoring to personalized strategic monitoring for your market.
Generalist, structured, and reliable monitoring, available in a weekly edition.
- European regulatory news
- Key European Commission decisions
- MDR 2017/745 & IVDR 2017/746 developments
- News on AI-containing MDs (AI Act)
- Standards updates (ISO 13485, etc.)
A solid foundation to stay informed effortlessly.
Targeted monitoring based on your activity, your devices, and the specifics of your market.
- Specialized sources tailored to your specific domain
- Regulatory impact analysis on your products
- Regulatory competitive analysis
- Risk and opportunity contextualization
- Critical alert prioritization for your product strategy
Strategic monitoring, built as a lever for anticipation and decision-making.
Why does this solution change your approach?
In a sector where regulatory compliance is unavoidable and every standard has an operational impact, SYNCHRO is designed to turn monitoring into a strategic lever.
Lighten the cognitive load
Regulatory monitoring for Digital Medical Devices is complex and time-consuming. Our artificial intelligence tool continuously analyzes European regulatory sources, then filters only the truly relevant information.
You no longer waste time searching, reading, and sorting: the essentials come directly to you, in a clear and structured manner.
Foster rapid and strategic decisions
In a constantly evolving regulatory environment, speed of access to information is key. Our solution allows you to immediately identify changes that may impact your products, your strategy, or your compliance.
You have reliable, prioritized, and actionable information to make the right decisions at the right time.
Shift from passive to proactive monitoring
Our AI helps medical device stakeholders anticipate regulatory changes rather than react to them. It continuously monitors authority decisions, regulatory and standards updates related to medical devices.
You are alerted as soon as a change becomes relevant to your activity. You approach audits, CE marking, and MDR / IVDR changes with confidence.
Accelerate your compliance throughout the product lifecycle
This AI monitoring was designed for the companies we support in CE marking and regulatory compliance. It addresses an obligation: staying constantly up to date without mobilizing internal resources on a complex subject far from their core business.
We handle the monitoring and analysis work for you. You stay compliant and focused on innovation and product development.
