From Concept to Clearance:
Regulatory & Quality Expertise
for Medical Devices
Helping medical device companies navigate FDA submissions, regulatory strategy, and ISO 13485 quality systems—without the cost of a full-time regulatory team.
With over 25 years of regulatory affairs and quality experience, NovoMedTek supports startups and established manufacturers from concept to clearance.
Regulatory Strategy
Services include:
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Device classification and regulatory pathway strategy
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Predicate device identification and regulatory landscape analysis
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FDA pre-submission planning
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De Novo and 510(k) strategy
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Global regulatory roadmap development
FDA & Global Submission Support
Our team prepares and manages regulatory submissions from start to finish.
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FDA 510(k) preparation and submission
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De Novo submissions
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Technical documentation for global markets
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Gap assessments and remediation
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FDA deficiency response support
Quality Systems & Compliance
Build a scalable quality system that supports growth and regulatory compliance.
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ISO 13485 Quality Management System development
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FDA QMSR readiness
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SOP development and implementation
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Design controls and risk management
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Internal audits and compliance support
Lifecycle Regulatory Support
Regulatory compliance does not stop at clearance.
We support companies throughout the product lifecycle.
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Change control strategy
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Post-market surveillance planning
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Global registrations and renewals
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Regulatory impact assessments
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Ongoing advisory support
ENGAGEMENT OPTIONS
We offer flexible consulting, tailored to your needs.
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Hourly consulting
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Project-based submissions
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Monthly regulatory advisory retainers
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Custom regulatory strategy packages
WHO WE WORK WITH
NovoMedTek supports:
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Medical device startups preparing for their first FDA submission
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Early-stage companies seeking regulatory strategy
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Established manufacturers expanding into new markets
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Companies implementing or improving quality systems
WHY CLIENTS WORK WITH US
Faster Market Access
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Clear regulatory strategy helps avoid costly delays
Investor & Board Ready
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We help companies present a credible regulatory roadmap to investors and partners
Flexible Expertise
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Access senior regulatory leadership without hiring a full-time team