Quality assurance (QA) processes are deeply embedded in all levels of the healthcare industry.
QA assists the project teams in ensuring that quality processes are implemented and regulatory requirements are maintained during the project.
Pharmaceutical and Biotechnology companies must have a Quality Management System (QMS) in place. Efficient maintenance of this system is a key factor for achieving safe and effective products in the healthcare industry.
Moreover, the European Medical Device Directive requires that the manufacturer’s quality system will be audited and approved by the notified body before granting the device a CE mark.
In the US, manufacturers must establish a QMS that meets the quality system regulation and which will be inspected either prior to, or after receiving regulatory approval to market the product.
We assist our clients to achieve this goal by providing the following services:
Quality management planning, Standard Operation Procedures implementation and training according to ISO 13485, 21 CFR 820 and other regulations as applicable
Corrective Actions and Preventive Actions (CAPA) procedures
Preparation for certification of Quality Management Systems (QMS)
according to ISO 13485 and required applicable regulations
Liaison with certification bodies
Pre-certification system reviews / audits prior to regulatory / notified body audits
Maintenance of certified Quality Management Systems (QMS)
System audits to certify clients’ vendors and suppliers