STUTTGART, GERMANY, 7 OCT 2019 – Intland Software, the Germany-based global provider of safety-critical software development tools, introduces new templates for developers of medical technology. Using these two templates with the company’s products, medtech businesses can simplify and accelerate regulatory compliance, and save a great deal of costs in the process.
Intland Software’s updated Medical Software Engineering Template comes preconfigured to support developers of healthcare technology in adopting best practices to achieve compliance with EU and US regulatory requirements (EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA 21 CFR Part 11 & 820). The template provides predefined assets, user-focused information, and a practical scenario that walks users through a fully compliant delivery process, making compliance attainable with less effort than ever before.
The company’s all-new Medical Audit & CAPA Template provides audit and compliance support for ISO 13485 and FDA Title 21 CFR Parts 11 & 820. The template extends Intland Software’s compliance coverage to Quality Management System regulations and document management capabilities. Users adopting the template can greatly simplify audit preparation and execution, as well as the management of Corrective and Preventive actions. These templates enable them to achieve consistently high-quality products and services while minimizing time and effort costs.