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.
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.
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.
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.
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.
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.