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We’re excited to announce the launch of our first digital QMS toolkit for software as a medical device startups! This QMS toolkit contains a full set of templates for laying the foundation for your quality system.
Why digital QMS toolkits?
After many years of working with medtech startups on building quality management systems, we know quite well that this is an intensive process and, let’s be honest, a bit daunting as a startup with limited resources and experience. More often than not, startups don’t know where to start. At Cosm, we love working with startups and wanted to create a set of do-it-yourself QMS toolkits that could make this process easier.
What’s included in the QMS toolkit?
Our first toolkit focuses on getting you through the design and development stages of a software development cycle and is aptly called the Pre-Market QMS Toolkit. This will get you all the way through your formal V&V efforts. We focus on pre-market first as we often advise startups to take a phase approach and tackle what’s needed for the current stage of the product cycle.
In the Pre-Market QMS Toolkit, you will find:
- A Quality Manual template
- Standard operating procedures (SOP) templates
- All related forms for SOP compliance
- Instructions and expert tips for every template
Additionally, we include guidance and expert tips with all of our templates, so you know exactly what to do with each one. In the end, you’ll have the foundation for your first QMS and be in compliance with ISO 13485 and 21 CFR 820.
As the famous saying goes, Rome wasn’t built in a day, and neither are quality systems. This is just the beginning. We’re working on a second toolkit focused on the post-market phase to help startups as they commercialize and build upon their quality systems.
Preview the QMS toolkit
In today’s competitive environment, efficiency and speed to market is key. If you’re looking for an easy, affordable, do-it-yourself approach to creating your first QMS, we invite you to learn more and preview our new toolkit here.
