On Time Service

ECM notified body 1282

Regulatory Approval Time is crucial. Whether you assign a dollar value to it or not, your time is valuable to ECM. The values and work ethic displayed by a company’s decision makers have a direct influence on company’s culture, and many times, on a business’ profitability. ECM improves the efficiency and effectiveness of your business.

On Time Service

ECM’s On Time Service is the most efficient solution to your CE and QMS ISO 13485 regulatory approval needs. ECM delivers unsurpassed service by upholding responsibility, teamwork and quality. Our primary commitment is to make regulatory approval a successful, smooth and streamlined path. On Time Service has earned a strong reputation in the regulatory world based on providing exceptional technical skills and superior service.

ECM’s On Time Service is executed on-site. Our experts will visit your facilities to finalize the requirements of Phase1 and Phase 2.

PHASE 1

On-site Technical Review

Report Review of Technical File, CER, QMS Manual are done

On-site

Engage in a dynamic discussion with RA of manufacturer to clear doubts and find solutions in real time

PHASE 2

On-site Audit

On-site audit for QMS

Scheduled once
Phase 1 is completed

Engage in a dynamic discussion with RA of manufacturer to clear doubts and find solutions in real time

PHASE 3

Final Review
Certification

Final review and deliberation of Decision Maker Committee

5 working days

From the closure
of NCs of Phase 2

Our services are not to be intended as a guarantee that CE Marking Certificate will be delivered within a certain number of working days. On time completion of the service is contingent upon client’s timing in resolving the reviews outcomes and ability to promptly react to the NCs.

Let's talk about

ECM America -Unit 506 – 1110 Brickell Avenue 33131
Miami, Fl

(833) 326-2378info@ecmmedicaldevices.com

ECM HQ - Via Ca' Bella, 243, 40050
Valsamoggia (BO)

+39 051 670 5141info@entecerma.it