Services
QMSR Compliance Services
Less than 50 days until February 2, 2026. The FDA's Quality Management System Regulation takes effect whether you're ready or not.
I offer five options based on how much support you need. Pick what matches your situation—or book a discovery call and I'll tell you.
FREQUENTLY ASKED QUESTIONS
Free Assessment
QMSR Readiness Snapshot
$0
Stop guessing about the February 2026 deadline. This free, automated diagnostic tool provides an instant assessment of your organization's preparedness for the FDA's transition to ISO 13485.
What you get:
- Instant Clarity: Get your personalized readiness score (RAG) in less than 5 minutes
- Identify High-Risk Gaps: Know exactly which QMS subsystems require urgent attention
- Data-Driven Prioritization: Move beyond guesswork with a structured assessment of your compliance status
- Zero Cost, Zero Friction: Access immediately—no budget approval or sales calls required
What you don't get: Expert review or personalized guidance. This is self-assessment, not consulting.
Team Access: Unlimited—share with your entire organization.
Best for: Any medical device company unsure where they stand on QMSR readiness.
For DIY Teams
QMSR QuickStart Pack
$39/month | $390/year (save 17%)
Digital templates and checklists for teams with internal QMS expertise who need proven frameworks, not hand-holding.
What you get:
- The Proprietary Gap Matrix: Essential blueprint for mapping 21 CFR 820 to ISO 13485—the exact crosswalk FDA expects you to document
- SOP Microguide: Step-by-step guidance for updating your procedures to meet QMSR requirements
- Terminology Crosswalk Excel: Side-by-side comparison of 820 vs. 13485 language to ensure compliant documentation
- Video Walkthroughs: Watch how to use each tool effectively
- Priority Email Support: Get answers within 24 hours
- Quarterly Updates: Templates updated as FDA guidance evolves
- Immediate Access: Download everything within minutes of signup
What you don't get: Direct consulting time. This is resources, not guidance.
Team Access: Per-company license—unlimited internal users. Share across your entire QA/RA team.
Best for: Companies with experienced QA staff who need tools, not consulting. Teams comfortable with self-directed implementation.
For Teams Who Need Expert Guidance
QMSR Crash Course
$199/month | $1,997/year (save 17%)
48-hour clarity. Know exactly where you stand and what to fix first.
You'll leave with a prioritized action plan—not a 200-page report that collects dust.
What you get:
- 90-Minute Expert Assessment: Virtual session with a certified ISO 13485 Lead Auditor reviewing your current QMS state against QMSR requirements
- QMSR Compliance Scorecard: Red/Amber/Green status across all QMS subsystems—see exactly where you're compliant, at risk, or failing
- Prioritized 30-60-90 Day Roadmap: Action plan tailored to your specific gaps, sequenced by risk and effort
- 30-Minute Follow-Up Call: Check-in 2 weeks post-assessment to answer questions and adjust priorities
- Session Recording: Full recording delivered within 24 hours for team members who couldn't attend
- Satisfaction Guarantee: Absolute clarity or full refund
What you don't get: Implementation support. This is diagnosis, not treatment.
Participants: Up to 3 team members in sessions. Additional participants: $297/person.
Who should attend: QA Manager or Director, Regulatory Affairs lead, and one executive stakeholder (VP Ops, CEO, or founder).
Best for: Companies who need expert validation of their gaps before committing to a remediation plan. Teams who can execute independently once they know what to fix.
Timeline: Assessment delivered within 48 hours of session.
Discovery call required—we'll confirm fit before you pay.
QMSR Strategy Intensive
$499/month | $4,997/year (save 17%)
Four-session strategic deep dive. We build your remediation roadmap together—your team executes with confidence.
What you get:
- Session 1 — Gap Analysis Deep Dive: Comprehensive review of your QMS documentation, processes, and records against QMSR requirements
- Session 2 — Prioritization & Risk Assessment: Score gaps by compliance risk, implementation effort, and business impact
- Session 3 — Remediation Roadmap Development: Build your week-by-week execution plan with clear owners and milestones
- Session 4 — Validation & Pressure Test: Stress-test your plan, identify blind spots, and finalize the path forward
- Complete Gap Analysis Report: Documented findings with prioritization matrix
- Custom Remediation Roadmap: Your execution blueprint—not a generic template
- Documentation Review: Feedback on your existing QMS documentation
- Email Support Between Sessions: Get answers as questions arise
- All Session Recordings: Delivered within 24 hours for team reference
What you don't get: Hands-on implementation. This is strategy, not execution support.
Participants: Up to 5 team members across all sessions. Additional participants: $497/person.
Who should attend: Cross-functional team—QA/QC leadership, Regulatory Affairs, Operations lead, Engineering representative. Decision-makers who will own the remediation work.
Best for: Companies with meaningful gaps who have internal resources to execute once they have a plan.
Outcome: Your team walks away with a sequenced execution plan and the confidence to implement it.
Timeline: 4 sessions delivered over 2-3 weeks, scheduled within 1 week of booking.
Discovery call required—we'll confirm fit before you pay.
QMSR Implementation Sprint
$2,499/month | $24,997/year (save 17%)
12 weeks of "done-with-you" implementation. Weekly coaching, documentation development, staff training, and mock FDA inspection.
For companies facing significant gaps with limited internal QMS expertise to execute.
What you get:
- Weekly Coaching Calls: 12 × 60-minute sessions guiding your team through execution
- Documentation Development Support: Templates, reviews, and feedback on your SOPs, work instructions, and quality manual updates
- Staff Training Materials: Training content for your team on QMSR changes and new procedures
- Mock FDA Inspection: Simulated inspection with findings report—know how you'll perform before the real thing
- Front Room Coaching: Prepare your team for inspector interactions—what to say, what not to say
- Remote Support Between Sessions: Direct line for questions as they arise
- The Hybrid Model Advantage: AI-accelerated efficiency (Virtual Backroom tools) combined with expert human coaching
- All Session Recordings: Full library for onboarding new team members
- Support Through February 2026 Deadline: We're in this with you until you're compliant
What "done-with-you" means: You execute with my templates, frameworks, and coaching. I guide, review, and validate—your team owns the work. This builds internal capability while ensuring you pass inspection. I don't write your SOPs for you; I make sure they'll hold up under scrutiny.
Participants: Up to 8 team members in weekly coaching calls. Additional participants: $997/person.
Who should attend: Full QMS project team—QA/QC staff, documentation owners, process owners, and at least one executive sponsor.
Scope: Single site, single QMS. Multi-site or multi-product-line implementations quoted separately.
Best for: Companies who need hands-on support to get across the finish line before the deadline.
Outcome: A QMS that passes inspection—not a binder that collects dust.
Timeline: 12-week engagement starting within 1-2 weeks of booking.
Payment options: 50% upfront, 50% at Week 6. Or 5% discount for full payment upfront.
Discovery call required—we'll assess scope and confirm fit.
Why QMS.Coach
Enterprise experience. Startup pricing.
I'm Neelank Tiwari—quality systems consultant with a track record at Fortune 500 medical device companies.
| Where | What |
|---|---|
| Medtronic | 40% reduction in audit findings as Enterprise Audit Readiness Program Manager |
| Endologix | 70+ supplier transitions for EU MDR compliance |
| Edwards Lifesciences | Quality engineering and process optimization |
Certifications: ISO 13485 Lead Auditor • CMDA • CQA • CSQP • PMP
Education: Bioengineering (UC Riverside) • MS Technology & Innovation Management • MIT Sloan AI in Pharma/Biotech
I don't sell 200-page audit reports that no one reads. I give you a plan you can actually execute—at a fixed price, with no surprises.
Not Sure Which Option?
Take the QMSR Readiness Quiz — 2 minutes, 12 questions. You'll know where you stand.
Or book a 30-minute discovery call. No pitch. I'll tell you which option fits your situation—or if you don't need me at all.
FAQ
How many people can participate?
| Package | Included | Additional |
|---|---|---|
| Readiness Snapshot | Unlimited | — |
| QuickStart Pack | Unlimited internal users | — |
| Crash Course | Up to 3 | $297/person |
| Strategy Intensive | Up to 5 | $497/person |
| Implementation Sprint | Up to 8 | $997/person |
Can different people attend different sessions?
Yes. Limits are per-session capacity, not named individuals. All sessions are recorded and shared within 24 hours.
Can I expense this?
Yes. All services include detailed invoices suitable for L&D or compliance budget reimbursement.
What if I need to reschedule?
Reschedule up to 24 hours before any session with no penalty.
What's your guarantee?
- QuickStart Pack: Full refund within 14 days
- Crash Course: Full refund if you don't walk away with clarity
- Strategy Intensive: Full refund after first session if we're not the right fit
- Implementation Sprint: We keep working until you're satisfied
Do you work with startups or just enterprise?
Both. My enterprise background means I know what FDA inspectors look for. My startup pricing means you can actually afford to get ready.
What if we need more than the Implementation Sprint covers?
Multi-site implementations, complex product portfolios, or severe gaps may need extended engagements. We'll scope it on the discovery call and quote separately—same fixed-price transparency.
What's the difference between this and traditional consulting?
Traditional firms charge $300-500/hour with open-ended timelines. A comparable gap assessment runs $15,000+. I use AI-powered tools to compress timelines and pass the savings to you. Fixed price, clear deliverables, no scope creep.
What does "done-with-you" mean?
You execute with my templates, frameworks, and coaching. I guide, review, and validate—your team owns the work. This builds internal capability while ensuring you pass inspection. I don't write your SOPs for you; I make sure they'll hold up under scrutiny.
What's the scope for Implementation Sprint?
Single site, single QMS. Multi-site or multi-product-line implementations are quoted separately after the discovery call.
Questions? Email neel@qms.coach
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