med-templates-1200-2Our preconfigured industry templates have helped safety-critical developers around the world save time and costs in their regulatory compliance & audit efforts. We’re now extending this line of templates with two new templates for MedTech innovators!

Regulatory compliance is a tough nut to crack. Whether you’re operating in the aviation & defense industry, the pharmaceutical sector, automotive embedded systems engineering, medical device development, or any other regulated sector, controlling the quality of both your products and processes is vital. Various standards govern the safety, reliability, and overall quality of these products, and developers have to devise their own ways of navigating this complex regulatory landscape. In the meantime, market pressure forces them to cut development time, costs, and risks.

Intland Software’s preconfigured templates have been designed to support these safety-critical developers. They come with baked-in domain knowledge, predefined but adaptable artifacts, and accessible best practices – all to simplify and accelerate regulatory compliance, and to save a great deal of costs in the process.

New Medical Templates for Software Engineering and Audit & CAPA

Today, we’re launching two new templates for developers of medical technology products.

Related news:

Intland Software Introduces Dedicated Templates for MedTech Compliance

Medical Software Engineering Template

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This new template is intended for use by MedTech product development teams to manage their medical device software design and engineering processes from requirements all the way through to validation. This Medical Software Engineering Template helps you achieve compliance with EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA 21 CFR Parts 11 & 820.

The template provides predefined artifacts and processes that may be flexibly customized to suit any scenario; built-in domain knowledge; and a practical scenario that walks your users through a fully compliant delivery process.

Overall, this template lets you access established best practices to make compliance attainable with minimal effort. Use the template to map, automate, control, and monitor your product delivery processes, and to ensure regulatory compliance in the delivery of high-quality health technology products. Adopting the template saves you configuration time, helps cut project costs, and greatly contributes to a reduction in risks.

Medical Audit & CAPA Template

This new template, designed to support Quality Assurance teams as well as internal and external auditors, helps ensure product quality while accelerating audits. This Medical Audit & CAPA Template enables teams to reduce the effort costs of achieving compliance with ISO 13485:2016 and FDA Title 21 CFR Part 820.

The template helps you maintain rigorous quality control across your entire development lifecycle. It provides Quality Management System and document management capabilities to help you achieve consistently high-quality products and services while minimizing costs.

Using this template, you can simplify the management of deviations from established processes. Manage all your quality documents, eForms and CAPA items, and Root Cause Analysis processes all in one place. Preset audit checklists will save your auditors a great deal of effort at inspections. Audits are greatly accelerated via built-in, exportable reports.

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All-round MedTech Development Support

Our new templates are standalone tools you can use independently to enhance your delivery and QA processes. It is their combination, however, that provides unparalleled synergies. The two templates together cover the entire process of developing high-quality medical technology, providing immense benefits for users looking to reduce product delivery times and costs.

Use these templates to empower your teams with customized processes & tools, and shorten your route to value and to successful compliance.

“As regulatory scrutiny increases, developers are facing growing compliance costs. That’s why we’re so excited to introduce these templates” said 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.”

Want to find out more? Access our informational brochures of these templates below, or reach out to us directly for more info. And if you’re in Munich this week, join us at MedConf 2019 to be among the first to see these new templates in action!

Medical Software Engineering Template I'm interested

Medical Audit & CAPA Template I'm interested