Systems Engineering Services
With today's increasing technology in health care, and the multi-faceted integrations of systems and technologies, there are increasing challenges and complexities that are effectively managed with a systems thinking approach.
Advantages of a Systems and Risk-Based Thinking Approach
- Reduced total development times AND costs.
- Reuse of existing assets, data, equipment, and technologies to maximize return across the organization.
- Promote high performing team cultures, increasing Agile team velocities, higher motivation levels from a sense of ownership and shared responsibility, leading to higher productivity levels across the organization.
- Certification assurance through organization-wide processes, tools and practices aligned with industry best practices and international standards (e.g. ARP-4754, ISO-15288).
- Model-based developments, cross-functional involvement, and simulation technologies to retire technical and business risk early, and strengthen the engineering life-cycle and delivery capability.
Benefits of increased Usability in system development
- Product design and product performance will improve.
- User satisfaction will increase, situation awareness will improve, increased confidence in safe and effective use.
- Since usability errors can be detected much earlier in the systems development cycle, the development time and the development cost for the user interface will be reduced.
- As a result of the improved software interfaces and overall product design, sales and revenue will increase.
- Because the user interface is easier to handle it will take less time to train users.
- Reduced maintenance costs, reduced personnel costs, improved user productivity, growing market share.
System Design & Development
Complete system design & development services with a systems and risk-based thinking approach involving cross-functional stakeholders and disciplined execution - leading to innovative solutions and accelerated market access.
- Product/ Program definition with cross-functional stakeholders' using business value assessment and competitive market analysis.
- Rapid prototyping and feasibility; reducing technical and business risks early.
- Alignment of design and development plans with regulatory strategy and compliance with international standards.
- System architecture balancing key technical and business stakeholder needs; for a holistic effective solution.
- Ensure product and process conformity to recognized international standards; including IEC 60601-1 series, IEC 62304, ISO 14971, product-specific special controls, among others.
- End-to-end development lifecycle, from Rquirements to Design Reviews, Integration, Verification and Validation, and Traceability.
- Maintain Design History File; Plans, Specifications, Requirements, Architecture, Design Description, Test Procedure, Validation Records, Labeling, Traceability.
- Maintain Risk Management File; Hazards Identification, Risk Management Summary, Hazard Analysis, Design FMEA, Usability FMEA, Fault Tree Analysis, Bowties Risk Analysis, aligned with risk management plan.
- Prepare and support FDA submissions for 510(k)s, IDEs and PMAs.
- Support Test Agency Submissions, including interface with the Test Agencies and Witness Testing at Test Lab (e.g. UL, CSA, TUV, NEMKO, Intertek, METLABS, etc.)
Using state-of-the-art technologies and tools, and building advanced multi-disciplinary designs to meet your requirements.
- Analog, digital, design, layout, verification
- MCUs, DSPs, FPGAs, CPLDs, ARMs
- Programmable logic, FPGA, CPLD, PLC
- High speed digital and analog circuit design, synthesis, simulations
- Lab Tools: ICE, JTAG, logic analyzers, oscilloscopes, spectrum analyzers
- Embedded, firmware, drivers, PC apps, mobile apps, web, cloud
- Simulations, model based development, test driven development, real-time systems, connected Internet-of-Things
- Frameworks: .NET, WPF, Laravel, MySQL, RESTful API, AJAX, web applications
- Operating Systems: VxWorks, OSE, Linux, Windows/IOT, iOS, Android
Take control of your organization through understanding and managing business and product risks.
- ISO 14971, IEC 60601-1, IEC 62304 and CFR 820.30 Design Controls compliance
- Risk management per ISO 14971, safety risk assessment with FTA, FMECA, dFMEA, uFMEA, pFMEA, Bowtie risk analysis, and SW hazard analysis
- Facilitate cross-functional risk management activities - per ISO 14971 for Design, Process, Usability, and Software Risk management.
- SOUP and LEGACY software validation & documentation
- Software safety classification, safety architecture and segregation
- Design History File audit, compliance gap analysis
- Support FDA 510(k) and PMA cert. submissions for Class II and III medical devices
We have extensive knowledge of FDA and EU regulations for medical device development and product risk management life-cycles. Compliance with FDA QSR, 21 CFR 820.30 design controls, MDD 93/42/EEC, ISO 13485, ISO 14971, EN/IEC 62304, IEC 62366, to support regulatory submissions for market access in the US and International markets. We can review your design history documentation and assist with filling any gaps to prepare a regulatory submission, including predicate research, literature reviewing, safety labeling, and risk management per ISO 14971:2012 international standard.
Contact us today to find out how we can assist with your product development needs.