Pricing
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Koala Tea With Neel LLC - Hourly Rate Card
| Service Category | Description | Hourly Rate |
|---|---|---|
| Consultation & Advisory | Initial consultation to assess needs, discuss challenges, and provide high-level recommendations. | $150 |
| Audit Readiness & Preparation | Review of existing QMS, development of audit readiness plans, mock audits, SME training, support during FDA inspections or Notified Body audits. | $175 |
| Supplier Quality Management | Supplier qualification, audits, performance monitoring, CAPA management, SCAR management. | $175 |
| Regulatory Strategy & Compliance | Guidance on FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other international requirements. Support with regulatory submissions (e.g., 510(k), CE marking), including technical documentation review. | $200 |
| Process Improvement & Optimization | Analysis of existing processes, identification of inefficiencies, development and implementation of process improvements using Lean Six Sigma and other methodologies. | $175 |
| AI Tool Implementation & Training | Assistance with implementing and using the "Audit Risk Predictor Agent" and other AI-powered tools for quality and compliance. Training sessions for staff on AI tools. | $200 |
| Documentation & Technical Writing | Creation, review, and revision of quality manuals, procedures, work instructions, validation protocols, and other technical documents. | $150 |
Notes:
- Rates are negotiable based on project scope, complexity, and urgency.
- Travel expenses, if required, will be billed separately.
- Discounts may be available for long-term retainers or bundled services.
Basic Compliance Audit
- Price: $500 - $1,000
- Description: A comprehensive initial audit to assess your current compliance status with FDA, ISO, and EU MDR regulations.
- What's Included:
- Initial consultation to understand your compliance needs.
- Full compliance audit with a detailed report of findings.
- Recommendations for corrective actions and improvements.
Advanced Compliance Solutions
- Price: $200/hour - Custom Pricing
- Description: Ongoing consulting services to maintain and enhance compliance. Ideal for businesses requiring regular audits and compliance support.
- What's Included:
- Regular compliance audits and monitoring.
- Custom solutions for quality management and process optimization.
- Continuous support and updates to ensure ongoing compliance.
AI-Driven Compliance Solutions
- Price: Custom Pricing
- Description: Bespoke AI solutions designed to optimize your compliance and operational processes.
- What's Included:
- Tailored AI-powered analytics and tools.
- Implementation of data-driven strategies to enhance compliance.
- Continuous optimization based on real-time data insights.
Freelance Project Management for Medical Devices
- Price: Starting at $200/hour
- Description: Specialized freelance project management services focused on regulatory compliance, supplier quality management, and process optimization within the medical device industry.
- What's Included:
- Project management for compliance audits and quality initiatives.
- Supplier quality management and process improvement.
- Customized project support to meet your specific needs.
- Special Offer: First-time clients can book a 60-minute discovery call for FREE to discuss their project needs and receive a tailored proposal.
Subscription Tiers
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Koala Tea With Neel
$11/month
Dive deeper with "Koala Tea With Neel".
As a premium member, you'll unlock exclusive content, resources, and tools tailored for professionals in the medical technology industry
- Exclusive Articles: Get unlimited access to all our premium articles, case studies, and in-depth analyses.
- Interactive Workshops: Participate in monthly workshops and Q&A sessions with Neel and other industry experts.
- Resource Library: Access a growing library of templates, checklists, and tools related to audit readiness, supplier management, and more.
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- Discounts: Enjoy exclusive discounts on KoalaT.ai consulting services and partner offerings.
Audit Essentials - 60 min call
$100/month
Initiate your journey into quality assurance with a foundational audit package. Drawing from best practices, this tier offers a solid start to supplier auditing and quality enhancement
- Initial consultation and assessment
- Basic supplier auditing
- Quality improvement recommendations
Advanced Audit & Quality Management - 60min call
$125/month
- Quality improvement strategy and implementation
- Comprehensive QMS and supplier auditing (Desktop Audit)
- In-depth expert Program Manager & Engineer consultation
- Custom AI Tool Development
Enterprise Excellence - 60min call
$150/month
- Comprehensive consultation and assessment
- Advanced supplier auditing with detailed reports
- Quality improvement strategy, implementation, and follow-up
- Priority support & access
- Achieve Enterprise Excellence
- Positively Floor Your Organization
- Audit & Compliance Program Management
- Weekly 1:1 & Guides & Custom Tools + (optional) Working Meeting