CROMSOURCE strongly believes in Quality by Design – a commitment to review from the very beginning all aspects of operations, with a view to proactively identify and prevent quality issues and operational threats rather than relying solely on the ability to react to issues when they arise. A detailed and reliable feasibility analysis is one of the crucial first steps in the process.
Quality management and quality assurance are of paramount importance at CROMSOURCE. Our commitment to Quality by Design is reflected in our certification according to the quality system ISO 9001 first achieved in 2002 when few others considered such accreditation important.
The quality system is thoroughly reviewed every year by external and independent auditors. In 2012, the the ISO 9001:2008 certification moved to the multi-site approach and in November 2017 we successfully completed the certification transition to the newly revised ISO 9001:2015 quality management systems standard. Clients of CROMSOURCE can be assured that their projects will be delivered to the highest standards of quality.
In addition, CROMSOURCE makes training of all staff a high priority. All of our staff undertake a specific and personalized training program to ensure that all competencies are in place for the entire project team. This means clients can rely on the quality of our project management team assigned to their study.
CROMSOURCE also supports clients through providing quality-related services, including the following areas:
- Audits of Investigators/Sites
- Regulatory Training
- Audits of Vendors
- Internal System Audits
- Regulatory Inspection Assistance
- Changes to EU Medical Device Legislation: What you need to know - White Paper June 2016
- Clinical Data for Medical Devices - Preparing for increased requirements in the EU - White Paper, 2015
- Medical Device Overview
- Clinical Evaluation Reports - White Paper, 2015
- Wound Closure - White Paper, 2014
- EU Recast of the Medical Device Directives: The Rocky Road to the new Medical Device Regulation - White Paper, 2014
- Language Requirements for EU Medical Device Labels - Multilingual, September 2012