In the rapid paced medical device market, time-to-market is critical. Any delay in getting your device to market will negatively impact revenue and market share, add significant staffing costs, and can reflect negatively on your brand.
There can be many speed bumps along the road to regulatory approval.
On Time Service from ECM is the most responsive and efficient solution to your CE marking and ISO 13485 QMS regulatory approval needs. ECM delivers unsurpassed service by committing to responsibility, teamwork and quality. Our primary commitment is to make regulatory approval a successful, smooth, streamline path. Our On Time Service is built on exceptional technical skill and superior service. And it is taking the regulatory world by storm
How does On Time Service work?
Pre-Assessment: ECM conducts a pre-assessment to evaluate the standing of the technical documentation to verify the onsite audit conditions are met.
Phase 1 – Onsite Review: Review of Technical File, CER and QMS Manual is conducted ONSITE at your facilities, engaging dynamically with our assessors and your regulatory affairs staff to understand findings and provide immediate responses aimed to mitigate and close the findings in real time, as they are issued.
Phase 2 – QMS Onsite Audit: The onsite audit is performed by ECM’s assessors. The audit is conducted with the participation of your Q.A. Manager, engaging dynamically with ECM’s auditors to understand findings and provide immediate responses aimed to mitigate and close the findings in real time as they are issued.