On-Site Testing Solutions
Navigate FDA Regulatory Pathways with Confidence
Expert 510(k) and De Novo submission guidance for medical device companies – from startups to established manufacturers.
Medical Device Regulatory Consulting provides specialized regulatory support for medical device companies navigating the complex FDA approval process. Our experienced team offers strategic guidance, submission preparation, and FDA liaison services to help you achieve clearance efficiently and cost-effectively.
The Regulatory Challenge
Bringing a medical device to market requires navigating the complex FDA regulatory landscape. Many companies face:
- Delays in regulatory approval due to incomplete or incorrect submissions
- Lack of in-house regulatory expertise, especially for novel devices
- High costs associated with regulatory missteps or resubmissions
- Extended time to market, leading to lost revenue and competitive disadvantage
- Potential for regulatory rejection, requiring costly rework or redesign
- Missed funding milestones affecting investor confidence
Our MedTech Regulatory Consulting service addresses these challenges with expert guidance tailored to your specific needs.
What We Do
Our comprehensive regulatory consulting services include:
- Delays in regulatory approval due to incomplete or incorrect submissions
- Lack of in-house regulatory expertise, especially for novel devices
- High costs associated with regulatory missteps or resubmissions
- Extended time to market, leading to lost revenue and competitive disadvantage
- Potential for regulatory rejection, requiring costly rework or redesign
- Missed funding milestones affecting investor confidence
What Choose Us
Unlike other Medical Device Consulting Firms. we offer:
- Specialized expertise in 510(k) and De Novo pathways
- Cost-effective solutions designed for startups and mid-sized companies
- Personalized service with direct access to experienced consultants
- Flexible, agile approach that adapts to your needs
- Deep understanding of startup and mid-sized company challenges
- Transparent pricing with clear deliverables
Who We Serve
We work with a range of medical device companies, including:
- Early-stage startups seeking their first FDA clearance
- Mid-sized manufacturers expanding their product lines
- Established companies requiring specialized regulatory support
Service Packages
Basic Package
- Regulatory pathway assessment
- Comprehensive strategy report
Standard Package
- Complete strategy development
- Comprehensive 510(k) or De Novo submission package
- FDA liaison services
Premium Package
- Complete strategy development
- Comprehensive submission package
- FDA liaison services
- Post-submission support (including responses to FDA queries)
Custom Solutions
Need something different? Contact us for a tailored approach to meet your specific regulatory needs.
Our Process
Initial Consultation
We assess your device and regulatory needs
Strategy Development
We create a comprehensive regulatory roadmap
Documentation Preparation
We develop and review all required submissions
Submission and Follow-up
We handle FDA communications and address any questions
Timeline Expectations
- 510(k): Typically 6-9 months from strategy to submission
- De Novo: Typically 9-12 months from strategy to submission
- Expedited timelines available for companies with completed documentation and testing
Team Expertise
Our regulatory consultants bring extensive experience in FDA submissions, with specialized knowledge in:
- Medical device classifications and regulatory pathways
- FDA submission requirements and best practices
- Technical documentation preparation
- Regulatory strategy development
- FDA communications
Success Metrics
Our Success Indicators
- High submission acceptance rate
- Reduced time to FDA clearance compared to industry averages
- Client satisfaction scores
- Successful FDA clearance without major deficiencies
Frequently Asked Questions
What is the difference between 510(k) and De Novo?
A 510(k) is for devices substantially equivalent to an existing device, while De Novo is for novel devices without a predicate, requiring a new classification.
How long does the FDA review process take?
The FDA aims to review 510(k) submissions within 90 days and De Novo within 150 days, but actual times may vary based on complexity and completeness.
Do I need clinical data for my submission?
This depends on your device type, classification, and predicate devices. We’ll help determine your specific requirements during our initial assessment.
What makes your approach more effective for startups?
Our flexible, cost-effective solutions are designed specifically with startups in mind. We understand resource constraints and provide clear, transparent pricing with focused deliverables tailored to your stage of development.
Ready to streamline your path to FDA clearance?
Schedule a free 30-minute consultation to discuss your regulatory needs and learn how we can help bring your medical device to market.