A document-based quality management system for healthcare providers at point-of-care.
Don’t compromise on the safety and reliability of your point-of-care 3D printed devices. Medviso’s document-based quality management system is the solution you need for a hassle-free implementation. With user-friendly templates, you can ensure the highest standards in your 3D printing process.
At Medviso, quality management is at the forefront of everything we do. We know that a good quality management system is more likely to produce a safe and effective, high-quality product for our users and, ultimately, the patients. As the use of 3D visualisation and 3D printing for clinical use at point-of-care is increasing, we recognise the need for a quality management system (QMS) that is easy to implement and follow.
From a regulatory point-of-view, according to the new regulation for medical devices (MDR) in Europe, a QMS for in-hospital manufacturing is required. Additionally, the FDA is also expected to release guidance documents on specific regulation of 3D printing in healthcare facilities within the near future.
A QMS does not only apply to the actual printing of a device, but also of the processes behind it, such as printer maintenance, training, testing, and documentation. Printing point-of-care devices means that testing of each device is not possible, instead you need to rely on process validation – meaning that you need to have control of your process to know when it fails.
Implementing a QMS may feel intimidating, but our QMS Point-of-Care is especially tailored to those without previous knowledge or experience with QMS’s and includes templates for the quality system, standard operating procedures, general and device templates, webinars, and personal support for you to get started immediately. We also offer support packages that includes help with your first internal audit. Contact us today for more information.