Skip The Line with
Express 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 culture, and many times, on business profitability. ECM strives to improve the efficiency and effectiveness of your business.

Express Service

ECM’s Express Service allows you to be on top of the timeframe of your regulatory approval, allowing you to plan and organize your regulatory, market and production activities to maximize efficiency in your company.

How does Express Service work?

PHASE 1

Technical Review

Report Review of Technical File,
CER, QMS Manual

In 10 working days
from the project kick-off

PHASE 2

On-Site Audit

On-site audit
of QMS

In 15 working days
from the closure of NCs of Phase 1

PHASE 3

Final Review – Certification

Final review and deliberation of Decision Maker Committee

In 5 working days
from the closure of NCs of Phase 2

**Post activity: one conference call, aimed to explain the findings, is included.

Express Service is not to be intended as a guarantee that a CE Marking Certificate will be delivered within a certain number of working days. Timing of ECM services is contingent on client’s timing in resolving the outcomes of reviews and on your 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