CE Certification
Get CE Certified with Confidence
The CE mark is a passport to the European market for medical devices, signaling that your product meets the EU’s stringent health, safety, and environmental protection standards. Aequum offers comprehensive support to manufacturers seeking CE certification under the MDR and IVDR.
Our experts guide you through the entire certification process, from initial product classification and conformity assessment to the preparation of technical documentation and interaction with notified bodies. Whether you're launching a new product or renewing certification for an existing device, we ensure full compliance, allowing you to sell your products across the EU with confidence.
Our CE Certification Services Include:
- Product classification and regulatory strategy
- Conformity assessments with notified bodies
- Compilation of technical documentation
- Risk analysis and clinical evaluation reports
With Aequum as your partner, you benefit from deep regulatory expertise and a
streamlined pathway to CE certification, allowing your devices to reach the EU market faster.