ISO 9001:2008 Certification

ISO 9001:2008 Certification

Aptiv Solutions is the leading CRO providing, among other areas of operations, dedicated medical device and consulting services, focused on delivering: strategic regulatory planning and support, US FDA and international regulatory submissions, global clinical trial design and execution, and quality assurance and compliance services to address the US FDA Quality System Regulation (FDA QSR) and ISO 13485.

Our medical device services are certified as conforming to the Quality Management System Requirements ISO 9001:2008. 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

Vision and Mission

Our vision is to be a market leader in designing and executing cutting edge drug and medical device development. Our mission is to develop and deliver forward thinking technologies and expert solutions for conducting global clinical trials to improve medicine and public health. With a talented and motivated staff, a commitment to rapid innovation, a global perspective and a personal touch, we strive to exceed our customers’ expectations by delivering high quality products and services.

Certification to ISO 9001:2008 and our corresponding Quality Policy support our vision and mission by:

  • Ensuring that we clearly understand our customers’ requirements and meet them in a timely and cost effective manner
  • Ensuring that we inspect and release all key customer deliverables only after following rigorous quality reviews
  • Maintaining our expertise in applicable regulations and other job skills impacting quality through ongoing training programs, including the employee training to meet the specific requirements of each medical device study

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.

To download a PDF copy of our ISO registration certificate click here.