Solve the Math

of Regulatory Time

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.

In business there’s a saying: Time is money.

The longer it takes to obtain the CE Certificate, the more it costs your business. It is crucial for medical device manufacturers to choose a Notified Body that can optimize technical processes to deliver an efficient certification program.

Choosing the right regulatory service for your business is the key to a smooth approval process.

In an era driven by disruptive needs, medical devices manufacturers can leverage ECM’s regulatory approval services to streamline several core processes including CE Marking, QMS ISO 13485, Testing, and value chain mapping.

ECM is a modern Notified Body. We saw the need to rethink the existing certification blueprints in-line with evolving requirement dynamics and market expectations. We strive to re-define the regulatory approval processes by delivering more efficient services across the main certification key points: Technical File review, CER review, QMS manual review.

We know that every business has its own unique challenges. Depending on your needs, you can take advantage of one of ECM’s signature services:

Let’s talk about costs.

Manufacturers are often blind-sided by hidden costs. Not accounting for these additional costs for CE and ISO 13485 regulatory approvals will exponentially increase your total go-to-market costs and lead to longer certification times.

ECM’s Express Service and the On-Time Service aim to reduce or to eliminate the hidden costs that directly impact your regulatory approval budgeting.

For example:

  • lost sales time
  • time and salary of regulatory staff
  • market share left to competition
  • costly additional reviews from NB
  • operating costs
  • back and forth communications and reporting
  • product inventory left unsold
  • staff unable to perform other activities
  • no added value activities
  • planning and scheduling of HR

Express Service and On Time Service maximize the ROI of your regulatory approval investment

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