Engineering

Our team of experienced engineers can help you with software development, electrical and mechanical design. We have extraordinary expertise with full stack software development, from embedded real-time and device control firmware, to desktop and mobile device apps and cloud backend/IoT infrastructure.

Our expert engineering workforce always applies lean agile and systems thinking in everything we do and routinely adopt best practices and leading technologies while following compliant development processes that create a Design History File and streamline a regulatory submission. With our deep regulatory and design controls knowledge the work product is always aligned to meet FDA and Notified Body expectations for streamlined successful submissions.

comprehensive

Project Management

Our project management services are tailored to your specific project needs - we can provide you with a turn-key managed team of engineering specialists including an integrated project manager - or provide you with specific specialists to integrate with your own engineering team. Our engineering workforce include multi-disciplined hardware/software engineers and scientists, full spectrum software (e.g. real-time, embedded, cloud, IoT, mobile app,dev-ops), verification & validation, and quality assurance/design quality professionals. In all of our customer projects we apply adaptive lean project management methodologies to ensure alignment to project priorities, cost and schedule, while limiting the work in progress to enable rapid adaptation to changing circumstances and/or new requirements.

We are obsessed with quality personnel matching and each of our engineering specialists is fully evaluated at a technical and interpersonal level to ensure successful integration with the project team. Our recruiters specialize in a wide range of medical device professionals including systems engineers, full-stack software engineers, mechanical engineers, and electrical engineers.

Systems of Systems Approach

At Medical Systems Consult we continuously apply a disciplined systems and risk-based thinking approach combined with state-of-the-art tools and agile methodologies to achieve exceptional results with great efficiencies on every project. 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. Our proprietary Systems of Systems approach is a proven product development model that effectively manages Quality, Risk, Schedule and Costs.

Advantages of Systems Thinking Approach

Reduced total development times and costs.
Emphasis on flexibility, adaptability, and customer value in the system development process.
Reuse of existing assets, data, equipment, and techniques to maximize return on investment.
Promotes high performing quality-oriented team cultures.
Reduced technical, clinical, and regulatory risks with continual cross-functional SME alignment.

Advantages of increased Usability & Design Thinking

Improved product performance with user-centric designs.
Superior user experience with higher confidence for safe and effective use.
Reduced usability errors and foreseeable misuse risks.
Easier to implement user interface and simpler user training.
Reduced maintenance, reduced complexity, and improved productivity.

System Design & Development

We provide complete medical device design & development services using a systems thinking approach to align the stakeholders' needs with disciplined project execution - leading to more predictable results and accelerated market access.

Our proprietary agile process engages SMEs early and continually to eliminate latent defect discoveries, and embeds the formal design input requirements directly in the agile stories/tasks to document the design evolution with traceability in the DHF with formal design reviews. This approach ensures design controls documentation is produced in a very short period of time without any rework.

Our engineering services

End-to-end design & development lifecycle, from Requirements to Design Reviews, Integration, Verification and Validation, and Traceability.
Rapid prototyping and feasibility; reducing technical and business risks early.
Product and feature definition aligned with cross-functional stakeholders, e.g., clinical, regulatory, R&D, product management.
System and software architecture balancing technical, business, and regulatory requirements.
Design quality and quality assurance professionals.

Alignment of design and development plans with regulatory strategy and compliance with international standards.
Design History File - Design and Development Plans, Requirements, Architecture & Design Specifications, Verification Protocols and Report, Design Input/Output Traceability.
Risk Management File - Risk Management Plan, Hazard Analysis, Design /SW /Process /Usability FMEA, Cybersecurity Risk Analysis, Risk Management Report.
ALM and PLM tool integrations to streamline quality compliance with Agile methodologies.