Quality Management Systems

At Aquila Consultants, we offer complete paper and electronic quality management systems proven to meet FDA and international regulatory requirements for medical devices. Based on the extent of any systems your company may already have in place we provide complete new systems or upgrades to your current system. Our years of experience in the medical device industry provide proven systems and resources.

Internal Auditing

Does your organization have a dedicated staff of internal auditors or do your internal auditors have other responsibilities in their home departments?

Do internal auditor responsibilities ever conflict due to resource availability and business obligations?

If an internal auditor moves to another department with other responsibilities do you find yourself short of auditing resources?

When you contract internal auditing activities with Aquila Consultants, you can leverage your auditor resources to add flexibility and stay on track with your audit schedule, without adding additional regular employees.

We provide the necessary planning, auditing, and reporting activities. We provide a highly trained and experienced auditor with medical device industry experience and ASQ certification in the Quality Manager, Certified Quality Auditor, andCertified Quality Auditor - Biomedical bodies of knowledge for the U.S. FDA as well as ISO 13485 and CE Marking.

Let us help your firm by providing regulatory compliance insight and experience to add value to your auditing process.

Supplier Auditing

Does your organization have a dedicated staff of supplier auditors?

When you contract supplier auditing activities with Aquila Consultants, you can leverage your auditor resources to add flexibility and stay on track with your audit schedule, without adding additional regular employees.

We provide the necessary planning, auditing, and reporting activities. We provide a highly trained and experienced auditor with medical device industry experience and ASQ certification in the Quality Manager, Certified Quality Auditor, and Certified Quality Auditor - Biomedical bodies of knowledge for the U.S. FDA as well as ISO 13485 and CE Marking.

Let us help your firm by providing regulatory compliance insight and experience to add value to your auditing process.

Training

We provide training materials and sessions either on-site at your facility or in a self paced electronic media format to make the best use of your time. Training topics cover all aspects of a medical device related registered manufacture or supplier. We provide a highly trained and experienced trainer with medical device industry experience and ASQ certification in the Quality Manager, Certified Quality Auditor, and Certified Quality Auditor - Biomedical bodies of knowledge for the U.S. FDA as well as ISO 13485 and CE Marking.

Let us help your firm by providing regulatory compliance insight and experience to add value to your training process.