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Design Article

LDRA tool suite serves to prove IEC 62304 medical compliance

Anne-Francoise Pele

9/4/2012 5:40 AM EDT

PARIS – LDRA (Wirral, UK) announced that Esprit Lean, a France-based safety-critical systems development company, has selected the LDRA tool suite to prove compliance of medical technology being developed to assist in cancer treatment.

Esprit Lean said the LDRA tool suite provides the static analysis and standards verification required to achieve compliance to IEC 62304. The objective is not only to implement coding rule compliance but also to enhance productivity, to adopt standardized style and code comments and to eliminate errors at the programming level, the company noted.


Synchro Module: Radiation therapy system for cancer treatment

Esprit Lean said it started development by configuring the LDRA tool suite to meet company programming standards as well as those of IEC 62304. The LDRA IEC 62304 template streamlined configuration, detailing the steps for process workflow and standards compliance. The company said LDRA’s graphically displayed analysis identified sub-functions and quickly performed a thorough analysis, helping the team work iteratively toward compliance.

In parallel, Esprit Lean said it has harnessed the LDRA tool suite to enforce common process, methodology and coding practice. It has created a consistent process workflow in which errors are promptly identified and addressed.

The following V diagram illustrates how LDRA tool suite can help through software development process described by IEC 62304.


Figure 1 - Mapping the capabilities of the LDRA tool suite to the guidelines of IEC 62304

Click here to enlarge the image.





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