We support the quality and regulatory needs of each program
We support the quality and regulatory needs of each program under design controls per our quality management system. We conduct formal design review meetings throughout each program, complete risk management activities, and control all documentation in a project file or a design history file, depending on the quality system used.
Design Review
We conduct formal, documented evaluations of each medical device's design at various stages of development in design review meetings. We ensure that the design meets specified requirements, identify potential issues, and confirm readiness to proceed to the next phase.
Risk Management
We complete risk management activities throughout each program, which involve identifying, assessing, and mitigating potential risks associated with a device throughout its lifecycle. We ensure that devices are safe and effective for users through risk analysis, risk evaluation, risk control, and monitoring residual risks.
Quality Management Support
We provide quality support to help implement or maintain quality management systems and ensure that devices meet quality requirements. This includes supporting design controls, process controls, corrective and preventive actions (CAPA), and regular audits.
Regulatory Support
We provide regulatory support to ensure that devices meet regulatory requirements. This includes assistance with premarket notifications (510(k)), premarket approvals (PMA), investigational device exemptions (IDE), and compliance with quality system regulations.
What's the ROI on Better Product Development?
Better design and development drive measurable outcomes. Organizations that achieve improved product development enhance quality through better device usability and functionality, reduce the cost of product development and cost of goods sold, accelerate time to market for product launches and future product iterations, and increase innovation with more protectable intellectual property.
Our Approach
We simplify complex design and development challenges
We help biomedical innovators understand complex challenges and create simply effective solutions. From concept generation and product brand strategy, industrial design and product development to verification and validation, we help commercialize biomedical innovations with our design and development services.
Discovery
We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.
APPROXIMATE TIMING: 1-2 DAYS
Assessment
We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.
Approximate Timing: 1 week
Statement of Work
We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, cost, and key milestones.
Approximate Timing: 1-2 weeks
Your innovationJust Mightchange the world. But is your design up to the task? We help you turnJust MightintoJust Mighty.
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