Systems Engineering Regulatory Compliance Risk Management Legacy SoftwareMedical Systems

Project Management Services



Our project management services are tailored to your specific project needs, providing you an integrated team of specialists including a project manager, multi-disciplined engineers and scientists, verification & validation, and quality assurance professionals.

With our unique ability to evaluate the right candidates at a technical level, we can supply Quality candidates that are a perfect fit for your requirements. Our recruiting specialties include systems engineers, mechanical engineers (disposables, DFM/ DFT, rapid prototyping), electrical engineers (analog, digital, high-speed, safety isolation), and software engineers (embedded, drivers, PC Apps, Mobile Apps, Web/ Cloud).

  • Intimate real-time tracking of project progress, scope, schedule, budget, and risks, with early feedback to allow making adjustments.
  • Project management following Agile and Scrum methodologies to optimize team velocities, maintain execution oversight and assure predictable results.
  • Evaluation and deployment of modern business management and development tools to maximize workflow efficiencies, and ensure continued compliance with design controls and electronic records regulations.
  • Temporary contracting/ specialist for multidisciplinary fields; Systems, Software, 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.

Taking a holistic systems 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 thinking approach combined with state-of-the-art tools and methodologies to execute on every single project. Our proprietary Systems of Systems approach is a proven product development model effectively manages Quality, Risk, Schedule and Costs.

See our Systems Engineering page for more information about our systems thinking approach to product development.

 

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.

 

Medical Systems Consult has extensive experience managing multi-faceted projects in the life sciences industries, with expertise ranging from systems engineering, system design & development (hardware and software), product safety certifications, Agile project management, DHF audits, ISO 13485 Quality Management Systems, holistic risk management, and other many other fields including in-vitro diagnostics (IVD) and health IT.

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

 

Read more about example projects here.