Quality System Development
Whether you are looking for an entire quality system developed to fit your business from scratch, a process within the quality system defined or a single SOP written we have been there done that and can be of assistance.
Contract Auditors
Our team of experienced auditors will review your system using the “process approach”, and will represent your company during your initial or continuing assessment audit with your notified body.
CAPA Assistance
Qualitas can help you establish a CAPA system or can assist you in maintaining an already established system. From writing Corrective and Preventative Actions to reviewing effectiveness of the CAPA system, we can work with your team.
Gap Analysis
Qualitas conducts a Gap Analysis to determine where your deficiencies lie as well as facility and QMS readiness for outside audits. We can conduct an onsite gap analysis or can conduct an analysis remotely through electronic file transfer.
Certified Safety Testing
Medical devices are required to show them perform safely and effectively… certified safety testing at a third-party test lab may be required prior to receiving FDA clearance and regulatory approval.
Risk Management
Qualitas can provide risk management activities and plans that meet the requirements of ISO 14971. We can help you through every step of the risk management process and will work side-by-side with you to streamline this process and help you achieve compliance.
Onsite Training
Classes on Quality System Management, ISO 13485, ISO 9001, Medical Device Compliance Standards (IEC 60601), and the risk management process can be set up to take place during an extended lunch or can range from a single day to multiple day training seminars.
Regulatory Support
Whether you need assist with your regulatory strategy or an entire FDA submission written, we are here to work side-by-side with your team.
Project Management
Qualitas has extensive expertise in managing medical device projects from concept to market entry. We work side-by-side with your team to manage / navigate the necessary device milestones in order to quickly and efficiently meet compliance objectives.