Get expert support
As a medical device innovator, you face the daunting challenge of navigating complex development and regulatory landscapes. Often, the path is littered with confusion and the threat of overspending on unnecessary services.
Solutions on your terms, when you need them
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Early prototyping
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Product strategy
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Intellectual property
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Technical feasibility
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Quality management
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Risk management
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Development planning
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Design controls
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Traceability
Avoid costly missteps in device development
Navigating the complexities of medical device regulations without expert guidance can lead to delays, lost resources, and missed opportunities.
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Large consultation packages burden your budget disproportionately
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Complex regulations overwhelm new medical device innovators
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Navigating quality management systems can be complex
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Implementing design controls feels overwhelming and unclear
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Essential documentation is often neglected and misunderstood
30%+
Regulatory submissions fail initial acceptance review
66%
Regulatory submissions require additional information, adding cost and time
35%
FDA citations relate to design controls and quality systems
Together, we can transform your vision into reality, navigating through the intricacies of the development process while minimizing costs and maximizing your impact on patient care.
Medical Device Development Roadmap
Need identified
Business Case
Regulatory Pathway
Development Strategy
Pre-production
Validation
Commercial Launch
Retirement
Innovative vision
Requirements
Proof of Concept
Detailed Design
Verification
Regulatory Clearance
Sustainment
Partner with an experienced guide
Supporting your vision with expertise
With over 10 years of experience, Axiom Management Solutions brings valuable insights gained from both established firms and innovative startups. Our expertise spans all stages of medical device development, from concept to commercialization, working across diverse platforms including electromechanical, interventional, and diagnostic devices.
Market Validation
Through rigorous market analysis, reimbursement evaluation and competitive positioning, we identify critical success factors for device commercialization.
Systems Engineering
Technical expertise to ensure that all elements of your innovation integrate in a cohesive solution meeting user needs and regulatory requirements.
Quality Management
Proven success guiding medical devices through FDA clearance and CE marking, with years of experience in the details of design control, risk management and traceability.
Project Management
Track record of delivering within budget and time constraints with a passion to exceed stakeholder expectations.
How to Get Started
Step 1: Contact
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Fill out the contact form with a description of your idea.
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​We'll schedule a call to discuss your needs.
Step 2: Proposal
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Detailed discussion about your innovation.
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Proposal to fit your budget and objectives.
Step 3: Execution
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Project kickoff.​
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Bring your vision to life!