With independent certification to IEC 62304, BlueBridge Technologies’ development processes meet the standard suitable for CE marking and FDA approval, giving clients and physicians the confidence that its products can be relied upon and trusted in the use of patient care.
FDA and CE Mark require a full suite of documented proof of the device efficacy and safety. This applies to software that is a component of a medical device, accessory to a medical device, or standalone software device.
The device classification determines the rigor expected. All parts of the quality systems can be applicable to software. Software components must be under design control, including software validation and risk analysis per 21 CFR 820.30. IEC 62304 is the accepted standard for both the FDA and CE mark for life cycle processes. Promenade Software provides the full software regulatory package with its engineering services.
Use of off-the-shelf (OTS) software must be analyzed for impact on safety if the OTS software fails. Cybersecurity activities must be applied and documented for networked devices.
Our experienced Verification and Validation team can perform all formal Independent Verification and Validation
(IV and V) testing, ensuring the highest quality software product. Our Independent Verification and Validation services improve software competence and comply with industry best practices, including IEC 62304 for medical software. Our services are cost effective, efficient and timely, with domain expertise you can rely on.