Strategic Consulting
Highly focused, consultative engagements designed to provide clients with clear and comprehensive strategies for achieving measurable results.
ALIGNMENT IS THE CRITICAL DIFFERENCE
Working with our clients’ executive management and senior technical leaders, we can deliver improved planning and development strategies, advanced technology approaches, technical advice and recommendations to align product technology and business goals. Clients receive a comprehensive blueprint on how to move forward confidently.
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Architecture Assessment
Architecture Assessment
Does your architecture meet quality attributes of performance, extensibility, maintainability, reliability, safety, and security while continuing to satisfy stakeholders? Will it support the next version of a product, can it transition to a product line architecture to support a family of products? Our comprehensive approach to assessing architecture employs multiple strategies that provide clients with insightful and actionable information to ensure that a software architecture is fit for its intended purpose.
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Cybersecurity Assessment
Cybersecurity Assessment
Drawing on our vast experience developing software with the highest levels of safety and criticality in the heavily-regulated Financial and MedTech industries, we ensure clients greatly improve their level of cyber hygiene. We can perform vulnerability assessments that review architecture and designs for threat vectors and provide prevention and mitigation plans. We can develop robust cybersecurity programs aligned with FDA guidance or review your current approach compared to FDA requirements. Our focus is to ensure that clients’ solutions feature robust security as a key component.
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Development Process Methodology
Development Process Methodology
With decades of experience working with various software development methodologies, we guide clients in the selection of the best development methodology for their project from the myriad of available options. With a clear understanding of project goals, our technical consultants can recommend a specific development methodology, leverage MedAcuity’s secure Agile process, or create a hybrid development methodology by combining elements of different methods. Our end goal is to provide clients with the methodology that will work best for their current project and get them to production more efficiently and securely while maintaining high quality.
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EOL Technology Migration
EOL Technology Migration
With technology advancing so fast, the end of its life is closer than you think. Knowing when and how to migrate and modernize existing technology while mitigating risk for end of life (EOL) is a very challenging business issue for some organizations. Let our highly skilled business and technical consultants provide an unbiased evaluation of available technologies and a set of recommendations based on a full view of the current application and its business value. Planning for and executing a successful migration event is possible.
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Gap Analysis
Gap Analysis
How do you know what needs fixing, changing, expanding or ditching to get your project or business to the next level? By comparing the current state of something with an ideal or future desired state, shortcomings and opportunities for improvement can be discovered. For over a decade and continuing today, we lead clients through a detailed examination of where they are currently and get them to where they want to be. A gap analysis can be executed for process improvement, cybersecurity compliance, QA process audit, project management, business and product strategy alignment, test automation approaches, and more. A well-executed gap analysis is a strategic management tool, providing decision makers with actionable recommendations and remediation plans designed to get you to your ideal or future state, sooner than you thought possible.
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Process Improvement
Process Improvement
Improvements to your development process can yield results that can be measured in enhanced product quality, increased productivity, employee skills development, and even customer satisfaction. Achieving any of these benefits starts with knowing where to look or what challenges to look for in your development process and team. We use a systematic approach that follows our proven methodology, adapted to each client’s unique organizational needs, to identify and validate pain points and uncover larger operational performance gaps. Clients receive a comprehensive analysis of tangible areas for improvement and solutions to address the findings.
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Project Planning
Project Planning
The missing link in many development organizations is detailed planning. A concept is just a starting point and without a detailed project plan, it will never amount to anything more than an idea. To quickly move your idea closer to reality, meticulous planning is a critical aspect to a successful software development project. Our approach ensures that a clear project scope is determined along with defining the means and ways that your new solution will meet strategic business objectives, resource availability, cost issues, and timeframes. With a comprehensive and well-thought-out plan, your concept is well on its way to becoming the new solution your customers are demanding.
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QMS & Regulatory Assessment
QMS & Regulatory Assessment
Quality Management Systems are key to demonstrating compliance with the demanding standards inherent in MedTech development. Don’t wonder if your organization’s QMS will hold up under the glare of a 483 warning letter. Working with a dedicated team of Quality experts, have confidence that your QMS will meet the FDA’s strict standards. Gain insights into the current state of your QMS with a comprehensive gap analysis report highlighting gaps and areas for improvement. Based on the gap analysis, we offer remediation plans designed to effectively update your QMS. We also offer process assessments relative to IEC 62304. Compliance to this demanding standard produces higher quality resulting in safer products which can help organizations avoid expensive recalls.
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Software and System Verification Strategy
Software and System Verification Strategy
We analyze requirements, architecture, and designs along with risk analysis to create detailed test plans consisting of strategies consistent with a risk-based approach. We develop a comprehensive set of protocols to test components in isolation and as a system. A focus on risk control measures, interfaces/integrations, and system test points ensure thorough test coverage, providing clients with peace of mind that their system meets requirements and functions as intended.
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Technology Due Diligence (M&A)
Technology Due Diligence (M&A)
With millions, even billions, of dollars at stake in a technology merger and acquisition (M&A), a third-party audit performed by our senior technical leaders can greatly assist in vetting your investment both before and post-transaction. Our objective assessment includes confirming assumptions, information gathering to plan the integration, and identifying risks in the technology, development processes and tools.
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Test Automation Strategy
Test Automation Strategy
Automation testing, a core activity of a QA test strategy, offers a tremendous ROI for product development—when done right and as part of a larger comprehensive Test Plan. Our skilled QA engineers assess products for test automation viability and formulate an effective approach that maximizes test coverage balanced with ROI.