Medical Systems Consult provides tailored contract services for all stages in medical device and software as a medical device (SaMD) product development, with specialties in full stack software development (cloud, mobile, embedded), systems engineering, risk management, and design controls for FDA Class II and Class III medical devices.

We specialize in custom digital health and mobile application development using state-of-the-art agile methodologies and advanced technologies such as cloud computing, SaaS, IoT, AI/ML, data science, and other enablers. We can help to significantly accelerate your product development delivery while maintaining design controls compliance and reducing the total development costs.


As your trusted development partner we can advise you of targeted upgrades & recommendations for application lifecycle management tools that integrate with your Quality Management System seamlessly to increase the overall Visibility, Traceability, Information, Agility, and Quality.


Our project management services are tailored to your specific project needs, providing you a managed integrated team of specialists including a project manager, multi-disciplined engineers and scientists, software engineers full spectrum (e.g. cloud, IoT, mobile app, embedded, real-time, dev-ops), verification & validation, and quality assurance professionals.

We systematically apply adaptive lean project management methods that facilitate alignment of work to the organization's overall strategy and enables prioritization of the most important work, while limiting work in progress and respecting the teams' capacity to deliver. This domain draws on our lean thinking, systems thinking, agile development, objective-centric risk management and strategic agility to achieve our clients' business goals and rapidly adapt to changing circumstances and/or new requirements.

With our unique ability to evaluate the right team members at a technical and interpersonal level, we can supply passionate Quality professionals that perfectly align with your project requirements. Our recruiting specialties include systems engineers, full-stack software engineers (mobile apps, web, cloud, full stack, embedded firmware, desktop, workstation), mechanical engineers (disposables, DFM/ DFT, rapid prototyping), and electrical engineers (analog, digital, high-speed, safety isolation).

  • Dynamic real-time tracking of project progress, scope, schedule, budget, and risks, with real-time feedback to allow making adjustments and contingency planning.
  • Project management following Agile Scrum and Kanban methodologies to optimize team performance and predictability, maintaining execution oversight and real-time status dashboards.
  • Integration of business management and application lifecycle management tools to maximize workflow efficiencies, re-use, modular architectures, and ensure continued compliance with design controls and electronic records regulations.
  • Contract staffing/ temporary specialists for multidisciplinary fields; Systems, Software, Mobile apps, Cloud full-stack, Mechanical, Electrical, Quality, V&V, Manufacturing, among others. We work with top nation-wide staffing agencies, and we always strive to supply quality pre-screened candidates. Our contract staffing services include assurance of supply at fixed rates and managed services.

Taking a holistic systems thinking, and risk-based thinking, approach to product development not only saves time and costs, but also ensures a quality product is produced that meets customer needs and adheres to all regulations. At Medical Systems Consult we continuously apply a disciplined systems and risk-based thinking approach combined with state-of-the-art tools and methodologies to achieve exceptional results with great efficiencies on every project. Our proprietary Systems of Systems approach is a proven product development model effectively manages Quality, Risk, Schedule and Costs.

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. We systematically apply adaptive lean project management and systems engineering methods that facilitate alignment of work to the organization's overall strategy and enables prioritization of the most important work, while limiting work in progress and respecting the teams' capacity to deliver. This domain draws on our lean systems thinking, agile development, objective-centric risk management and strategic agility to achieve our clients' business goals and rapidly adapt to changing circumstances and/or new requirements.

We systematically combine systems-thinking, critical-thinking, risk-based-thinking, design-thinking and lean-thinking to arrive at the optimal natural solution.

  • 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.
  • 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.

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
  • Programming languages: C, C++, C#, Java, JavaScript, PHP, Perl, VBA, HTML, CSS, XML, JSON
  • 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.

  Risk Management
  • 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, ISO/IEC 27001, 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.


Medical Systems Consult offers a wide range of Regulatory Compliance consulting services together with our associates and business partnerships with certified test laboratories. We have strengths in product safety conformity assessments for electrical medical systems including Electrical Safety, Basic Safety and Essential Performance, EMC, and Wireless Co-Existence certifications required to gain clearance in the United States, Canada, and European markets.

Our consulting services includes safety and risk management compliance, regulatory strategy consulting for Go-To-Market, quality management audits, FDA 510k/PMA/IDE and CE-Marking submission preparation and support. We always customize our services for each client's needs by bringing the right specialists and brightest minds in the specific field of application. You will get the same experts as the larger organizations, at significantly lower costs because at Medical Systems consult we are truly committed to providing you unbeatable value!

We can perform Quality Assessments of an established Quality Management System, or parts thereof, and technical documentation for a specific project/program, per ISO 13485 and/or MDSAP objectives, and consult with you on how to best bridge any gaps identified. Revisions to Standard Operating Procedures, or other process control documents are identified and generated; similar collaborations to address any gaps in project-specific Design History Files/technical documentation.


We have diverse knowledge and experience in medical device and software as a medical device (SaMD) regulations, and we can help ensure your successfull regulatory submission.

Our teams have expert-level knowledge in medical electrical safety standards, medical device software standards, information security and data privacy standards, and a broad multitude of international harmonized and recognized consensus standards.


Regulatory Submission Support

  • Prepare 510(k)s, IDEs and PMAs, and support submissions preparing responses to requests for additional information and other FDA correspondence
  • Bridge any gaps found in design history documentation creating new content as necessary and directing staff on how to maintain the end-to-end traceability of design controls past the submission and approval (post-market)
  • Preparation and assessment of Technical Files and Design Dossiers for European Directives (MDD, AIMDD, LVD, EMC) and Canadian Medical Device Requirements (CMDR) and DHFs (US)
  • Preparation of EU and/or CMDR Essential Requirement checklists and Risk Analysis per ISO or EN 14971


Standards Conformity

  • Product safety and EMC conformity assessments
  • Provide Product Safety Design Support, including: gap analysis/construction evaluation, independent review and generation of product labeling (including markings), and identification of safety critical components
  • Preparation of Clinical literature evaluations. Evaluation of Clinical data per MEDDEV 2.7.1 in accordance with the MDD/AIMDD
  • Review of product literature/packaging/labeling to MDD, AIMDD, CMDR, FDA, and IEC 60601 series (including general, collateral, and particular standards in series) requirements
  • Perform a gap analysis on a product for conformity with IEC 60601-1, 3rd Edition (Edition 3.0 or 3.1)
  • IEC 60601-1, 2nd OR 3rd Edition (Edition 3.0 or 3.1) product safety, essential performance and Risk Management File
  • IEC 60601-1-2, EMC design support including Test Plan Preparation, Essential Performance Analysis, Risk Management and related Labeling
  • Software Verification and Validation Protocols and Reports (IEC 62304, IQ/OQ/PQ, Tool Validations)
  • Support Test Agency Submissions, including interface with the Test Agencies and Witness Testing at Test Lab (UL, CSA, TUV, NEMKO, Intertek, METLABS, etc.)

  • Help maintain Company Standards and Regulations
  • Set up a complete Quality Management System (policies, procedures, work instructions), aligned with FDA, MDD, and CMDR regulations for Company
  • Audit Company to ISO 9000:2000/2015, ISO 13485:2003/2016, FDA QSR 21CFR820, MDD (EU CE Mark) and CMDR or MDSAP
  • Usability Engineering Process per IEC 62366:2016 and IEC 60601-1-6
  • Software Development Life Cycle (SDLC) processes for medical devices per IEC 62304
  • Risk Analysis, Risk Management, and Software Risk Analysis per ISO 14971 and IEC 62304
  • Supply medical device regulatory experts to support other fields including Sterilization, Biocompatibility, and Clinical Studies

Contact us today to accelerate your next regulatory submission and approval, e.g. FDA 510(k) and PMA, EU CE Marking via Notified Body.


Medical Systems Consult has extensive experience in the complete product development life-cycle for the life sciences industries. Our experience ranges from delivering limited scope work packages to managing complex multi-disciplinary projects with a large number of stakeholders. We assisted many successful Class II and Class III medical device project completions achieving regulatory approval at breakthrough speeds. Our product design and regulatory compliance services include systems engineering and system design, product certifications (e.g. Safety, CE, EMC), project management, DHF audits, quality management system audits, software/ hardware development, risk management, and other specialty fields within in-vitro diagnostics (IVD) and health IT.

We look forward to the opportunity to collaborate with your team, and help bring your next health innovation to market!