Developing safe and effective medical devices requires a balance of effective requirements management, risk mitigation, and automation. Controlling risk in this environment is also a function of cost and time, which device manufacturers must consider in their efforts to compete successfully. To achieve all of these goals, many device manufacturers are transitioning to the IEC 62304 standard in the hope that it will both help mitigate risk and expedite their path to device approval.
Manually following the processes, activities, and tasks identified in this standard can consume significant time and energy contributing to overall increased cost to clearance. Most companies try to reuse or leverage external libraries and code that is “proven in use” to shorten their development time and reduce cost. However, this typical software of unknown pedigree (SOUP) must still be considered in the overall evaluation of the security and safety and effectiveness of the device. Developers need strategies and technologies to verify these components through requirements-based testing. Equally important is the delivery of verification evidence and traceability throughout the software development life cycle to meet the needs of the regulatory authorities and support audits of the development process.
The LDRA tool suite is the most complete software verification and validation solution for the development of medical device software. These tools support the FDA and other medical device regulatory body guidelines from device development through device clearance and audit support.
The LDRA tool suite is the most complete software verification and validation solution for the development of medical device software. These tools support the FDA and other medical device regulatory body guidelines from device development through device clearance and audit support.
TÜV SUD and SGS-TÜV Saar have certified the use of the LDRA tool suite for security- and safety-critical development in the medical security and safety market under IEC 62304:2015, in recognition of LDRA’s own formal development and verification process and the capabilities of the LDRA tool suite.
Email: info@ldra.com
EMEA: +44 (0)151 649 9300
USA: +1 (855) 855 5372
INDIA: +91 80 4080 8707