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Spotlight Article: SPK and Associates
Our medical device customers report that up to 70% of new product innovation is being created in the software domain. This represents an increase in both volume and complexity.
In addition, the FDA has intensified the review process of medical device companies with a strong focus on software quality in order to comply with regulations. Our medical device customers routinely follow the EN/IEC 62304 standard for software design of medical products as their compliance playbook. Conformance with this standard provides evidence of having a software development process in place, and fulfills the requirements of 21CFR820 as well as the Medical Device Directive 93/42/EEC.
The challenge presented is how best to set up your development environment to achieve compliance with 62304 while also maintaining engineering efficiency. This article explores how we’ve leverage PTC’s Integrity platform to accomplish this.