Launching an in vitro diagnostic (IVD) device in Europe can feel like climbing Everest. That’s exactly why Cert 3 Global is the partner you need. With deep regulatory expertise and a full suite of IVDR CE Marking Services, they manage the tough parts so you don’t have to.
Expert Guidance from Day One
Straight off, Cert 3 Global begins with a gap analysis. They compare your current status with what’s required under IVDR. This isn’t guesswork, it’s a start-to-finish compliance roadmap. From there, they craft your regulatory strategy with clear milestones and timely deliverables.
By partnering with them, you avoid costly pitfalls. You stay ahead of changing regulations. And importantly, you move confidently toward achieving IVDR CE marking without headaches.
Document Management You Can Count On
A solid technical file is the heart of IVDR CE Marking Services. Cert 3 Global takes full ownership of this, including:
- Compiling clinical evidence, performance evaluation, and risk assessments
- Ensuring labelling, instructions, and packaging meet Annex I requirements
- Drafting the Declaration of Conformity and assembling all supporting documentation
This attention to detail avoids review cycles and keeps the Notified Body happy. Plus, you end up with consistent, high-quality documentation throughout the submission process.
Notified Body and Authority Liaison
Regulatory language can feel like a foreign tongue. That’s where Cert 3 Global steps in:
- They prepare submission packs that are ready for review no missing pieces
- They schedule and handle interactions with the Notified Body
- They manage any follow-up reviews or requests post-submission
Their proactive stance and industry know-how significantly shorten review times. You avoid delays and keep your launch timeline tight.
Ongoing Vigilance and Post-Market Support
Getting your IVDR CE marking isn’t the finish line; it’s just the start. After CE marking, you still need to stay compliant. Cert 3 Global supports you with:
- Post-market surveillance systems to detect and track incidents
- Field corrective action plans and reporting mechanisms
- Regulatory updates and adjustments to your technical files
- Market surveillance readiness and audit support
That kind of end-to-end oversight ensures your product remains compliant and market-ready for the long haul.
Why Cert 3 Global is the No-Brainer Choice
Partnering with Cert 3 Global offers tangible advantages:
| Benefit | How You Win |
| Speed to Market | Streamlined submissions and fewer delays |
| Hidden-Risk Avoidance | Precise regulatory navigation avoids issues. |
| Cost-Efficient Compliance | No need for in-house teams or extra training |
| Total Peace of Mind | They handle every step, from start to finish |
They’ve walked this path before. They know the regulations inside and out. And they work obsessively to keep your IVDR CE Marking Services timeline tight and regulatory risk low.
Common FAQs
1. How long does CE marking typically take?
It varies by device class and Notified Body availability. But with Cert 3 Global’s streamlined process, timelines are significantly shorter than DIY attempts.
2. What does gap analysis reveal?
It identifies missing or insufficient documentation in areas like clinical evidence, risk files, and labelling, providing a clear to-do list for compliance.
3. Can Cert 3 Global handle all documentation?
Yes. From developing risk assessments to assembling the full technical file, they keep everything accurate and audit-ready.
4. Is post-market upkeep included?
Absolutely. They help with surveillance, incident reporting, regulatory updates, and audit support to keep your device compliant.
5. Do they deal directly with Notified Bodies?
Yes. They prepare submissions, manage meetings and communications, and ensure timely follow-ups on review comments.
Unlock Compliance—Without the Headaches
With Cert 3 Global, you gain a compliance partner who prevents regulatory surprises. Their IVDR CE Marking Services cover every phase, ensuring your product meets Europe’s exacting standards.
They take the weight off your shoulders from initial analysis to CE marking, and beyond with post-market vigilance. You avoid risk. You avoid delays. And you avoid unnecessary costs.
Ready to simplify your IVDR CE marking journey? Reach out to Cert 3 Global now and secure expert support every step of the way.
