IEC 62304 SLDC Solutions

IEC 62304 SLDC Solutions

CRO Group is ready to help bring your medical device software, SaMD and Digital Health apps to market.  Since 1996, we have supported client’s software development life cycle activities and in the FDA and EU submission processes.

From planning and rapid prototyping, to risk management, to coding and testing, to integration and V&V, we’ll work alongside you preparing the SDLC deliverables required for Design Controls and premarket submissions. Whether you are  developing new

We start by fully understanding your development approach and the product requirements. We’re used to using all the popular AGILE/Kanban development and tracking tools including JIRA, GitHub, and Visual Studio.  We’re also proficient with all the current and vintage programming languages so we can keep the SDLC documents up to date with each sprint.

Clients have told us how much they appreciate our swim lane development process – we integrate QMS Design Controls, SDLC, and Risk Management so that applicable requirements of ISO 13485, 14971, 62304, and 62366  are all integrated together.  It also makes things straightforward if the medical device includes hardware (as in the case of most wearables, surgical robots, and other safety critical systems), and the PEMS requirements of IEC 60601-1 are applicable as well. Most Notified Bodies require documentation of compliance with these harmonized standards as evidence of “state of the art” for CE Marking under the MDR and IVDR.  With this approach, SDLC is usually not as painful or time or resource consuming and your talented software developers can stick to what they love, and get the project done on time.