Frequently Asked Questions
Everything you need to know about working with QMS.Coach.
General Questions
What is QMSR and why does February 2, 2026 matter?
QMSR (Quality Management System Regulation) is the FDA's modernization of 21 CFR Part 820—the regulation that has governed medical device quality systems since 1996. Starting February 2, 2026, manufacturers must comply with ISO 13485:2016 as the foundation of their QMS, with additional FDA-specific requirements layered on top.
This isn't optional. Companies that haven't transitioned by the deadline face enforcement risk, including Form 483 observations, warning letters, and import alerts. The FDA has been clear: the compliance date is firm.
Who is QMS.Coach for?
We specialize in helping small and mid-size medical device manufacturers—typically companies with 10-200 employees who don't have dedicated regulatory affairs departments or enterprise consulting budgets.
Our clients typically include:
- Post-clearance startups: Companies with recent 510(k) clearances scaling toward commercialization
- Growth-stage manufacturers: Organizations adding products or expanding operations
- Established companies: Manufacturers without internal QMSR transition expertise
If you have a 50-person regulatory team and a seven-figure compliance budget, you're probably not our target client. We built QMS.Coach for everyone else.
What makes QMS.Coach different from traditional consulting firms?
Three things:
1. Fixed pricing with clear deliverables. Traditional consultants charge $300-500/hour with open-ended timelines. You never know what the final bill will be. We quote a fixed price for defined outcomes—if scope creeps, that's our problem.
2. AI-accelerated efficiency. Our "Virtual Backroom" toolkit compresses research, gap analysis, and documentation review that traditionally consumes hundreds of billable hours. We pass those efficiency gains to you.
3. Enterprise expertise at SMB pricing. Our methodologies come from quality programs at Medtronic and Edwards Lifesciences. Our pricing assumes you don't have a Fortune 500 budget.
Do you work with companies outside the US?
Yes. QMSR applies to any company selling medical devices in the US market, regardless of where you're headquartered. We work with manufacturers in the EU, Canada, Israel, and Asia who need US market compliance.
All sessions are conducted virtually, so time zones are the only logistical consideration.
Can I expense this?
Yes. All services include detailed invoices suitable for L&D, compliance, or quality budget reimbursement. If you need a specific format or additional documentation for procurement, let us know.
Pricing & Payment
What's included at each price point?
| Package | Price | What You Get |
|---|---|---|
| Readiness Snapshot | Free | Automated RAG assessment, gap identification, prioritization guidance |
| QuickStart Pack | $39/mo or $390/yr | Gap Matrix, SOP Microguide, Crosswalk Excel, video walkthroughs, priority email support |
| Crash Course | $199/mo or $1,997/yr | 90-min assessment, QMSR compliance scorecard (RAG), prioritized 30-60-90 day action plan, follow-up call |
| Strategy Intensive | $499/mo or $4,997/yr | 4 sessions, complete gap analysis, prioritization matrix, custom roadmap, documentation review |
| Implementation Sprint | $2,499/mo or $24,997/yr | 12 weeks coaching, documentation development, staff training, mock inspection, front room coaching |
Why are these prices so much lower than other consultants?
Our Hybrid Model. We use AI-powered tools (the "Virtual Backroom") to accelerate work that traditionally consumes hundreds of billable hours—regulatory research, gap analysis, documentation review, audit preparation.
A traditional gap assessment from a Big 4 consulting firm or specialized regulatory consultancy runs $15,000-$25,000. Our Crash Course delivers comparable clarity for $1,997.
We're not cheaper because we're less experienced. We're cheaper because we're more efficient.
What payment options do you offer?
- QuickStart Pack: Monthly ($39) or annual ($390, save 17%)
- Crash Course: Monthly ($199) or annual ($1,997, save 17%)
- Strategy Intensive: Monthly ($499) or annual ($4,997, save 17%)
- Implementation Sprint: Monthly ($2,499) or annual ($24,997, save 17%). Payment plan: 50% upfront, 50% at Week 6. Or 5% discount for full upfront payment.
We accept all major credit cards through our payment processor.
Do you offer refunds?
- QuickStart Pack: Full refund within 14 days if templates don't meet your needs
- Crash Course: Full refund if you don't walk away with actionable clarity after the first session
- Strategy Intensive: Full refund after first session if we're not the right fit
- Implementation Sprint: No refunds after kickoff, but we keep working until you're satisfied with the outcome
We'd rather over-deliver than argue about refunds.
Participants & Team Access
How many people can participate in each package?
| Package | Included Participants | Additional Participants |
|---|---|---|
| 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. The participant limit is per-session capacity, not named individuals. Your QA Director might attend all sessions while your Engineering lead joins only the relevant ones.
All sessions are recorded and delivered within 24 hours, so anyone who misses a session can catch up.
Who should attend from our team?
Crash Course (up to 3):
- QA Manager or Director
- Regulatory Affairs lead
- Executive stakeholder (VP Ops, CEO, or founder)
These should be decision-makers who can act on the findings. Don't send observers—send people who own the compliance outcome.
Strategy Intensive (up to 5):
- QA/QC Manager or Director
- Regulatory Affairs lead
- Operations lead
- Engineering representative
- Executive sponsor (recommended)
These should be decision-makers who will own the remediation work. Don't send observers—send people who can commit resources and make calls.
Implementation Sprint (up to 8):
- Everyone above, plus:
- Documentation owners (SOP writers)
- Process owners (production, supplier quality)
- Training coordinator
The Sprint is execution-focused. You need the people who will actually do the work.
What if we have a large team and need more participants?
Contact us. For teams larger than 12-15 people, we may recommend splitting into functional cohorts or restructuring the engagement. We'll figure out the right approach during the discovery call.
Scope & Deliverables
What's included in the Gap Matrix?
An Excel-based crosswalk mapping every requirement in 21 CFR 820 to the corresponding ISO 13485:2016 clause. Each row includes:
- 820 requirement text
- Corresponding 13485 clause
- Key differences and gaps
- Common compliance pitfalls
- Recommended remediation approach
It's the foundation for your internal gap assessment—the same framework we use in our consulting engagements.
What does the RAG scorecard look like?
Red/Amber/Green ratings across all QMS subsystems:
- Document Control
- Design Controls
- CAPA
- Supplier Management
- Production Controls
- Management Responsibility
- Measurement & Analysis
- And 8+ additional sections
Each subsystem gets:
- Compliance status (R/A/G)
- Risk rating (High/Medium/Low)
- Priority ranking
- Key gaps identified
- Recommended next steps
You'll see exactly where you're solid, where you're at risk, and where you're failing.
What's the difference between "done-with-you" and "done-for-you"?
"Done-with-you" (our model): We provide frameworks, templates, coaching, and expert review. Your team does the implementation work. You build internal capability while we guide you to compliance.
"Done-for-you" (traditional consulting): Consultants write your SOPs, build your QMS, and hand you a finished system. You get compliance documents but no internal expertise—and a bill for $75,000-$150,000+.
We believe done-with-you is better for most companies. Your SOPs need to reflect how your company actually operates, and your team needs to understand and own them. A QMS built by outsiders rarely survives first contact with an FDA inspector asking "how do you actually do this?"
Do you write our SOPs for us?
No. We provide SOP templates, review your drafts, give detailed feedback, and help you revise—but your team writes the final documents.
This is intentional. SOPs that don't reflect your actual processes are worse than useless; they're liability. We make sure your documentation is compliant and accurate.
What if we need more help than the Implementation Sprint includes?
We'll scope it during the discovery call. Situations that may require extended or custom engagements:
- Multi-site implementations
- Complex product portfolios (Class III, combination products)
- Severe gaps requiring remediation before QMSR transition
- Companies under FDA enforcement action
We'll quote these separately with the same fixed-price transparency.
Process & Timeline
How quickly can we start?
| Package | Typical Start Time |
|---|---|
| Readiness Snapshot | Immediate |
| QuickStart Pack | Immediate access after signup |
| Crash Course | Within 5-7 business days of booking |
| Strategy Intensive | Within 1-2 weeks |
| Implementation Sprint | Within 1-2 weeks (limited availability) |
We cap concurrent Implementation Sprint clients to ensure quality. If we're at capacity, we'll let you know the next available start date.
How long does each package take?
| Package | Duration |
|---|---|
| Readiness Snapshot | 5 minutes |
| QuickStart Pack | Self-paced (most teams complete initial gap assessment in 2-4 weeks) |
| Crash Course | ~2 weeks (assessment + follow-up call) |
| Strategy Intensive | 2-3 weeks (4 sessions) |
| Implementation Sprint | 12 weeks |
Can we accelerate the Implementation Sprint?
Possibly, depending on your team's availability and gap severity. We've compressed to 8-10 weeks for highly motivated teams with strong internal resources and clear priorities.
We'll discuss timeline flexibility during the discovery call.
What happens after we complete a package?
You'll have clear next steps regardless of which package you chose:
- Snapshot → QuickStart Pack or Crash Course (depending on gap severity and internal capability)
- QuickStart Pack → Crash Course or Strategy Intensive (if you need expert guidance after DIY assessment)
- Crash Course → Strategy Intensive or Implementation Sprint (depending on gap severity and internal resources)
- Strategy Intensive → Implementation Sprint (if you need hands-on support to execute)
- Implementation Sprint → Post-Implementation Retainer (optional ongoing support)
We don't pressure upsells. If you're ready to execute independently, we'll tell you.
What if I need to reschedule a session?
Reschedule up to 24 hours before any session with no penalty. Life happens—we get it.
For Implementation Sprint clients, we build schedule flexibility into the 12-week timeline. A missed week doesn't derail the engagement.
The Discovery Call
What happens on the discovery call?
A 15-30 minute conversation to understand your situation:
- Current QMS state and documentation
- Team size and QA/RA resources
- Product portfolio and regulatory pathway
- Deadline pressure and risk tolerance
We'll recommend the right package—or tell you if we're not the right fit. Some companies genuinely don't need us. We'd rather say that upfront than take money for services you don't need.
No pitch, no pressure.
Do I have to do a discovery call before purchasing?
| Package | Discovery Call Required? |
|---|---|
| Readiness Snapshot | No |
| QuickStart Pack | No |
| Crash Course | Yes |
| Strategy Intensive | Yes |
| Implementation Sprint | Yes |
For consulting engagements, we want to confirm fit before you invest. The discovery call protects both of us.
What should I prepare for the discovery call?
Nothing required. Helpful if you can share:
- Current QMS documentation status (even a rough sense)
- Any recent FDA inspections or audit findings
- Team size and QA/RA headcount
- Target compliance date
- Specific concerns or questions
Don't stress about preparation. We'll ask the right questions.
Credentials & Approach
What are your qualifications?
Neelank (Neel) Tiwari brings enterprise quality experience from Fortune 500 medical device companies:
| Company | Role/Impact |
|---|---|
| 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 (Exemplar Global)
- Certified Medical Device Auditor (CMDA)
- Certified Quality Auditor (CQA)
- Certified Supplier Quality Professional (CSQP)
- Project Management Professional (PMP)
Education:
- BS Bioengineering, UC Riverside
- MS Technology & Innovation Management
- MIT Sloan Artificial Intelligence in Pharma/Biotech Certificate
What is the "Virtual Backroom"?
Our proprietary AI-powered toolkit that accelerates compliance work:
- Regulatory research and interpretation
- Gap analysis and prioritization
- Documentation review and feedback
- Audit preparation and simulation
It's how we deliver enterprise-quality outcomes at startup-friendly prices. The technology is developed by KoalaT.ai LLC, our sister company focused on AI tools for regulated industries.
The "backroom" reference comes from FDA inspections—it's where your team prepares responses and pulls documentation while inspectors review the front room. Our Virtual Backroom gives you that preparation advantage before inspectors arrive.
Do you guarantee FDA compliance?
No consultant can guarantee FDA compliance—that's ultimately determined by inspectors and your company's execution.
What we guarantee:
- You'll have a clear, actionable path to compliance
- You'll understand your gaps and priorities
- You'll have the tools and coaching to execute
- Implementation Sprint clients will be audit-ready by engagement end
If you do the work, you'll be prepared. We can't control whether you do the work.
Technical & Logistics
How are sessions conducted?
All sessions are virtual via Zoom or Google Meet (your preference). We record every session and deliver the recording within 24 hours.
For Implementation Sprint clients, we also use a shared workspace (Notion or Google Drive) for documentation review and collaboration.
What time zones do you support?
We're based in the US (Pacific Time) but work with clients globally. We'll find a time that works—early morning and evening sessions available for international clients.
Is my information confidential?
Yes. We treat all client information as confidential. For Implementation Sprint and Strategy Intensive clients, we're happy to sign your NDA or mutual NDA before engagement.
We never share client names, documentation, or findings without explicit permission.
Still Have Questions?
Email: neel@qms.coach
Book a call: [Discovery Call Link]
We respond to emails within 24 hours (usually faster).
Last updated: December 2025