Medical device companies need to establish a Quality System to meet regulatory requirements. CQ has a proven track record in developing Quality Systems to meet FDA scrutiny and obtain ISO 13485 certification.
CQ can build your Quality System from scratch. We can also work with your existing procedures to help you ensure compliance. We've been through FDA Quality System inspections and ISO certification audits. We know what these inspectors expect in a medical device Quality System.
REGULATORY / COMPLIANCE
Regardless of the market for your medical device, there are regulatory and compliance concerns that you must address.
CQ authors regulatory submissions, such as FDA 510(k) submissions and CE mark technical files. We see these submissions all the way through, ensuring your products gain regulatory market clearance.
On the compliance side, our knowledge and experience with FDA inspections and ISO audits should be an asset to your company.
The roots and foundation of CQ is Project Management. You need to get things done. This is what we do. Whether you have a new product development project, a quality system initiative, or a regulatory submission, CQ will manage your projects to completion.