Our vast design-case body of knowledge, library of compliant documentation templates, and streamlined process solutions, can greatly reduce project risk and execution timelines.
Several customers need an affordable prototype to capture funding, gather use-case information, complete requirements elicitation, or to establish a Minimum Viable Product. In most cases, the need for a prototype comes with urgency and the need to contain costs. We maintain a range of effective prototyping techniques such as software re-use, reference designs, vendor-supplied development boards, rapid fabrication, and modularity to deliver functionally representative solutions in minimal time. We streamline our documentation to establish the most efficient requirements capture and configuration management possible, without compromising the integrity of the data. Most importantly, Realtime’s prototypes are designed to specifically deliver the understanding needed from a prototype
Secure IoT & Connected Device Design
As the demand for connectivity with endpoint devices increases exponentially, challenges in power management, bandwidth, cyber security, and radio interference become ever greater. Use case requirements are driving more complex interfaces, often with multiple channels and/or connection mediums. Whether introducing a new IoT functionality, or adding connectivity to an existing device, designers must not only comply with regulatory standards, but also anticipate the environmental changes the device will experience. Experienced system designers know how to properly leverage modularity in order to preserve the FCC license and minimize the amount of testing for approvals.
Quality Systems and Compliance
Navigation through the compliance pathway requires not only expertise, but also a current working knowledge of the changes in the framework and interpretation of standards, new or updated guidance documents, and applicable regulations.
If you need to develop a Quality Management System (QMS) from scratch, we have a set of templates that are readily tailored for your business practices. If you have an existing QMS, it may need to be updated to align with the current and evolving regulatory landscape. We can conduct a gap analysis on your system and provide guidance on updates to meet current expectations.
If you have audit findings, feel your systems are inefficient or ineffective, or get the dreaded 483 or warning letter, we have helped numerous companies with their remediation efforts.
Realtime also maintains a library of technical documentation package templates that facilitate product documentation compliance for regulatory submission.
Realtime stays abreast of new / draft FDA guidance documents; MEDDEVs; standards changes (e.g., 13485, 14971, 62304, 62366, 60601-1, just to name a few); and regulatory changes.
Realtime can provide solutions to a wide variety of test needs ranging from product Verification and Validation to development of automated test equipment and automated software test to equipment qualification, process validation, and test method validation.
Our protocols ensure sufficient data is captured to meet regulatory requirements and execution is performed with focus on data integrity. We can perform full traceability between requirements and tests and provide trace analysis to support claims of test coverage and to support change impact assessment. Our software test services ensure test data required by regulatory bodies, beyond verification of requirements. We can develop usability studies, including summative protocols. Even if you’ve conducted your own product testing, Realtime can provide fresh insight through our exploratory test methods and ‘condition collision’ testing.
We can design and instrument automated test beds for a wide range of applications and can conduct necessary qualifications on the equipment and test method validations on the approach. We also provide simulation-based testing capabilities, developing the physics and interface modeling, Monte-Carlo drivers, automated output analytics, and model validation.
As experienced algorithm developers, Realtime has a unique understanding of the close relationship between systems engineering and algorithm design. Although the range of possible expertise is vast, we know the discipline of robust algorithm development and how to approach most problems. We have specific experience in Kalman filtering and estimation, open-loop and closed-loop control law design, target tracking adaptive control theory, RF signal processing, video processing, Machine Vision, 6DoF simulations, data science, data processing, and a number of related disciplines. Our people also have great depth in efficient matrix math and statistical computations, numerical conditioning and translating algorithms from Matab or Python scripts into C/C++.
Redesign for Obsolescence
Typical electronic obsolescence issues occur when parts or support are no longer offered by the original vendor and may include the complete spectrum of electronic components from CPUs, processors, DSPs, FPGAs, transceivers, memory chips, discreet analog and digital components, active and passive components, connectors and cabling etc. It is often also discovered in the case of older systems, that the corporate knowledge and understanding of design intent has eroded over time. Our obsolescence redesign process includes a methodical assessment of existing design knowledge, and where necessary, a methodical process of reconstructing that knowledge.
Services we provide in this domain include technical obsolescence studies, product redesign and reverse engineering, identification of replacement (form, fit and function) parts, life time buy analysis and procurement, obsolescence investigation and analysis, design trade studies, prototyping, fabrication, integration, assembly, inspection, qualification testing, and technical documentation.
We utilize a layered approach of applying incrementally investigative reverse engineering strategies, beginning with collection of existing data sources such as Interface Control Documents (ICD), Operator’s Manuals, and Troubleshooting Manuals. If necessary, we then glean Operational knowledge and system requirements through in-depth conversations with end-users and equipment operators. Realtime will also leverage our relationships with Non-Traditional Informational Resources (NTIR) to gain additional insight about system operation. Realtime’s unique breadth of experience in the engineering services market has allowed us to develop strong professional relationships with Subject Matter Experts (SME), Field Applications Engineers (FAE) for many electronics parts Manufacturers, Suppliers, and Contract Manufacturers, as well as with other professional contacts.
If investigative efforts aren’t enough, emulators and simulators will be used, where possible, to further understand software and circuit functionality. Finally, Realtime’s experienced test team in conjunction with their systems engineering group will perform testing on available systems or circuit boards to determine operational functionality as well as identify system inputs and outputs. Combining the system knowledge culled from each of these sources will allow Realtime to flesh out the system specification and derive hardware and software specifications, as needed.