Continued competition, global markets, recall concerns, and stringent FDA regulations have made product documentation more critical than just fulfilling a labeling requirement. A user-focused documentation process is the most efficient way to control costs without delaying product launches or risking recalls. We will plan, design, develop, produce, and maintain your medical device product documents so you can focus on creating a great product.
Medical device manufacturers have until May 2020 to meet new compliance standards. With our EU MDR compliance solution, you'll transition with ease.
Medical devices are only as effective as their sales, service, and users. Make yours as powerful as possible by ensuring its safe and accurate use. While gathering the knowledge and developing accurate and usable reference materials is time-consuming and complex, falling behind is not an option. That’s where Novatek comes in.
Novatek provides product documentation and training that is error-free and on time, including:
We can also keep your organization’s quality systems process documentation up to date and compliant using:
A properly documented quality system can help speed compliance and reduce risk. Download our free checklist to see if your process is audit ready.