Aptiv Solutions’ medical device services continue to be certified as conforming to the Quality Management System Requirements ISO 9001:2008, following a systems audit of its medical device operations. These services include:
- Regulatory document development, preparation, and submission, including Investigational Device Exemptions (IDEs), Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs) and Technical Files
- Clinical trial design, study management, monitoring, data management, and statistical analysis
- Quality system design, implementation, training, auditing, and compliance assistance to ensure compliance to US FDA Quality System Regulation, ISO and CEN standards, and Canadian and European Union (EU) quality requirements
- General consulting and special projects
This ISO 9001:2008 certification is evidence of a robust system of policies, practices, and procedures developed to meet one overarching objective – to ensure that clients receive consistently high quality services and work product.
“Our decision to achieve and maintain ISO 9001:2008 certification is a proactive one that demonstrates our commitment to providing the highest quality medical device operational and consulting services to our clients, now and into the future,” states Vicki Anastasi, senior vice president, Medical Devices.
To maintain this certification, Aptiv Solutions is subject to semi-annual audits. In addition, every three years the company will complete a verification audit to ensure compliance and assess initiatives for continued improvement.