Quality assurance and QMS compliance
Our Quality Assurance experts are trained professionals in the guidance and implementation of QMS compliance, mainly on ISO 13485:2016
- QMS Implementation
- ISO 13485 transition program
- Pre certification Gap Analysis
- ISO 13485 Audits
Our QA experts are experienced in the process to accommodate the implementation of your ISO 13485:2016 quality management system. We are committed to facilitate your needs and to ensure that there is involvement throughout the organization to make the implementation last.
ISO 13485 transition
CE medical is committed ensure a smooth transition to the ISO 13485:2016 regardless if you are making the transition from the 13485:2003 or EN ISO 13485:2012. Act now if you are still in the process of making the transition and make sure to be ready before February 28, 2019.
Pre Certification Gap analysis
When you are in the process of preparation for a certification, CE-Medical can carry out a Gap analysis. This Gap analysis is an assessment of existing processes and procedures within your organization, this will be compared with the requirements of the standard. This outlines the compliance gaps and clearly indicates the weaknesses on which you need to take immediate action before the audit takes place.
ISO 13485 Audits
The ISO 13485:2016 standard and regulatory requirements dictate that medical device companies and manufacturers have to conduct regular (internal) audits of their Quality Management Systems. CE-Medical provides auditing by certified lead auditors in order to independently review your quality system. We assist you in passing the Notified body audit and comply with applicable regulations.
This also applies in case your product is manufactured by a contract manufacturer. CE-Medical can conduct on-site supplier audits.