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.
“As regulatory scrutiny increases, developers are facing growing compliance costs. That’s why we’re so excited to introduce these templates” says Reka Moksony, Intland Software’s QA Manager. “By offering Engineering and Quality Management support in two very adaptable, modular templates, our customers can tailor a solution to their specific needs to drive cost reduction. And users looking for a 360-degree solution to their compliance needs can derive significant benefits from combining these templates.”
In addition to the medical domain knowledge and best practices baked into these templates, Intland Software also offers specialist consulting and support services. Developers of healthcare technology can receive comprehensive assistance to optimize their engineering, quality management, and audit processes.
“Our new templates provide a combined solution for medtech developers. When used together, these templates fulfil both product (design) control and process control needs” says Szabolcs Agai, the consultant contributing expertise to the creation of these templates. “We’re seeing great value in offering preconfigured templates to help users hit the ground running. They are able to realize immense time and cost savings, both key considerations in a health technology market characterized by fierce competition and fast tech innovation”.