Systems Engineering Regulatory Compliance Project Management Risk Management Legacy SoftwareMedical Systems

Consulting Services


services

Medical Systems Consult specializes in systems engineering and design controls for FDA Class II and Class III medical devices.

We can help accelerate your next regulatory submission and approval, and cut some development costs. Medical Systems Consult delivers technical and regulatory expertise for all stages of medical device development.

 
 

As a trusted development partner we can advise you of targeted upgrades & recommendations to your existing Quality Management System and business process management tools, both for compliance with regulations, and to unleash your organization's full potential.

 

services

Whether you're seeking compliance, or looking for improvements, with ISO 13485, FDA 21 CFR Part 820 & 803, MDD 93/42/EEC, or Health Canada CMDR, we can help achieving that goal. We have extensive experience with design controls regulations and we can establish new design controls processes -or- make targeted improvements to existing processes for higher efficiencies. Our Quality and Regulatory teams are ready to lead, or support, 510k or PMA submissions or inspections with the FDA, Health Canada and EU Competent Authorities.

 

Project Management

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.

See our Project Management page for more information about our robust product development services.



 

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Systems of Systems Approach

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.

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



Regulatory Compliance

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.

Learn more about our Regulatory Compliance services to support your commercial initiatives at all product phases. 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 Experience

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!

 

Read more about example projects here.