Where to start when there are so many things to consider? Compliance to standards and regulations (e.g. IEC 60601, Medical Device Directive 93/42/EEC and FDA CFR 21 parts 11 and 820), safety risk management (e.g. ISO 14971), approval processes and many other mandatory procedures needing tool support. It is not possible to start small with the medical device industry, but it is possible to start easy with Taipuva’s medical ALM template for Polarion.
Template includes a basic version of all essential processes and reporting needed for quick Polarion deployment in medical device company: requirements engineering, verification & validation, safety risk control, change management, issue management, design review, document review & approval and meeting memos.
Instead of starting from scratch, you can start with a simple working solution and develop it step-by-step for your needs. All you need to start a trial or proof of concept with your project is Polarion installation with the medical template and a short training session.
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