Accelerate Your Medical Device Certification

Expert Documentation Services for MDR 2017/745 and ISO 13485 Compliance

Our Services

• Comprehensive Documentation Support: We assist in the preparation and review of all necessary documents to ensure compliance with MDR 2017/745 and ISO 13485 standards.

• Direct Collaboration with Notified Bodies: Our partnerships with leading Italian Notified Bodies streamline the certification process, reducing time to market.

• On-Site Surveillance Scheduling: We coordinate on-site audits, providing clear timelines to keep your certification on track.

Why Choose Us?

• Specialization in Dental Medical Devices: Our expertise is tailored to the unique needs of dental device manufacturers.

• Efficient Certification Process: By acting as a direct intermediary, we expedite all certification steps, ensuring a smooth and timely experience.

• Regulatory Expertise: Stay ahead of regulatory changes with our in-depth knowledge of MDR and ISO standards.

Contact Us

Ready to simplify your certification journey? Contact us today to learn how we can assist you in achieving compliance efficiently and effectively.