Health Technology Software
Kasve provides versatile services that support medical software developers in product development and regulatory management.
Medical software includes both so-called stand-alone medical device software and software embedded in a medical device. Kasve provides versatile services that support medical software developers in product development and regulatory management.
Kasve has solid experience in constructing the product development process required in medical software development and modelling this to ensure that documentation required by the EN 62304:2006/A1:2015 standard on software lifecycle processes is produced during the product development process.
Kasve will also assist our clients as needed in charting, introducing and configuring the required development tools.
Moreover, we will help you make sure that your project is progressing according to plan and on schedule, and ensure that you carefully prepare the documentation required by legislation.
Our services are also available as ELY Business Development (Kehpa) Day services!
Product Development Health Check
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.
eQMS
An efficient, easy-to-use and modern quality management system for a medical device manufacturer.
Outsourced Software Development Project Manager
Kasve’s Software Development Project Manager ensures that your software development is proceeding with a goal-oriented and systematic approach.
IEC/EN 62304 Workshops and Training
The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.
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