EARLY ACCESS
VANTA FOR FDA COMPLIANCE
FDA compliance, computed
Know what applies to you, what changed, and prove every review - before the FDA asks.
NSF research–backed founder · Design partners in the US and UK
NSF research–backed founder
Design partners in the US and UK
NSF research–backed founder
Design partners in the US and UK
EARLY ACCESS
VANTA FOR FDA COMPLIANCE
FDA compliance, computed
Know what applies to you, what changed, and prove every review - before the FDA asks.
NSF research–backed founder · Design partners in the US and UK
Design partners in the US and UK
NSF research–backed founder
Design partners in the US and UK
Regulatory change monitoring
Know the minute it changes
The Federal Register moves whether you're watching or not. Kalypsis watches twice daily and flags it the same day — not at your next consultant review.
Regulatory change monitoring
Know the minute it changes
The Federal Register moves whether you're watching or not. Kalypsis watches twice daily and flags it the same day — not at your next consultant review.
Regulatory change monitoring
Know the minute it changes
The Federal Register moves whether you're watching or not. Kalypsis watches twice daily and flags it the same day — not at your next consultant review.
FDA gap analysis, computed
Most of the FDA isn't your problem
Kalypsis computes which obligations land on your device class, stage, and quality system. 1,664 tracked. 250 apply to you. 7 need you this month.
FDA gap analysis, computed
Most of the FDA isn't your problem
Kalypsis computes which obligations land on your device class, stage, and quality system. 1,664 tracked. 250 apply to you. 7 need you this month.
FDA gap analysis, computed
Most of the FDA isn't your problem
Kalypsis computes which obligations land on your device class, stage, and quality system. 1,664 tracked. 250 apply to you. 7 need you this month.
Continuous compliance evidence
Prove every compliance decision
Continuously analyze code health and runtime behavior to catch critical issues early — with clear priority, context, and ownership.
Continuous compliance evidence
Prove every compliance decision
Continuously analyze code health and runtime behavior to catch critical issues early — with clear priority, context, and ownership.
Continuous compliance evidence
Prove every compliance decision
Continuously analyze code health and runtime behavior to catch critical issues early — with clear priority, context, and ownership.
Features
Compliance should be proactive - not reactive
Compliance shouldn’t slow your company down. It should be how you earn trust with regulators, investors, and customers.
Computed obligation scoping
Continuous change detection
Citation-bound review
One system, every framework
FDA today; EU MDR, EMA, and MHRA on the same obligation model. One regulatory state, not one project per jurisdiction.
Computed obligation scoping
Continuous change detection
Citation-bound review
One system, every framework
Computed obligation scoping
Your obligation set is derived from your org profile, device class, stage, quality system, not a generic checklist. 1,664 tracked. 250 apply. 7 need you this month.
Continuous change detection
Citation-bound review
One system, every framework
Benefits
Turn compliance into your biggest asset
Scoped to you
Your obligation set is computed from your org profile, device class, stage, quality system, not copied from a generic checklist.
Scoped to you
Your obligation set is computed from your org profile, device class, stage, quality system, not copied from a generic checklist.
Always current
Twice-daily monitoring of the Federal Register and CFR. Changes are diffed against your obligations automatically.
Always current
Twice-daily monitoring of the Federal Register and CFR. Changes are diffed against your obligations automatically.
Continuous tracability
Reviews are bound to the specific regulatory text, down to the citation — not just a document title and a date.
Continuous tracability
Reviews are bound to the specific regulatory text, down to the citation — not just a document title and a date.
Tamper-evident by design
Evidence that can't be quietly edited after the fact — by anyone. Every attestation is cryptographically sealed to the one before it.
Tamper-evident by design
Evidence that can't be quietly edited after the fact — by anyone. Every attestation is cryptographically sealed to the one before it.
Inspection-ready, always
No more weeks of audit prep. Your proof bundle is assembled continuously and exportable in one click.
Inspection-ready, always
No more weeks of audit prep. Your proof bundle is assembled continuously and exportable in one click.
Clear regulatory states
FDA today; EU MDR, EMA, and MHRA on the same obligation model. One regulatory state, not one project per jurisdiction.
Clear regulatory states
FDA today; EU MDR, EMA, and MHRA on the same obligation model. One regulatory state, not one project per jurisdiction.
Comparison
Why modern teams choose Kalypsis
Other tools
KALYPSIS
Gap analysis
Gap analysis
6 - 12 weeks
Minutes
Minutes
Obligation tracking
Obligation tracking
Signature binding
Signature binding
Document-level
Citation-level
Citation-level
Change monitoring
Change monitoring
Manual review
Continuous
Continuous
Audit trail
Audit trail
Evidence lineage
Evidence lineage
Inspection readiness
Inspection readiness
Weeks of prep
Always ready
Always ready
Global coverage
Global coverage
Separate projects
Unified
Unified
Update cost
Update cost
Per engagement
Flat rate
Flat rate
Scaling effort
Scaling effort
New engagement
Instant
Instant
Need a custom plan?
Need a custom plan?
We can tailor workflows, limits, and infrastructure to fit your team’s needs.
How it works
From protocol to approval,
continuously validated
Step 1
Detect
Monitor FDA regulations, guidance, and standards as they evolve.
Step 1
Detect
Monitor FDA regulations, guidance, and standards as they evolve.
Step 2
Map
Map regulatory obligations to your products and quality system.
Step 2
Map
Map regulatory obligations to your products and quality system.
Step 3
Prove
Generate audit-ready evidence for every compliance decision automatically.
Step 3
Prove
Generate audit-ready evidence for every compliance decision automatically.
FAQs
Got questions?
We’ve got answers.
Still have questions?
Contact us and we’ll help you out.
01
What does Kalypsis actually do?
Kalypsis computes which FDA regulations apply to your organization, monitors them for change continuously, and binds every compliance review to the exact regulatory text — producing a tamper-evident audit trail you can hand to an inspector. Think Vanta, but for the FDA.
02
How much does an FDA gap analysis normally cost?
A consultant-led gap analysis typically runs $15K–$40K, takes 6–12 weeks, and starts going stale the day it's delivered. Kalypsis computes yours from your org profile in minutes and keeps it current as the CFR changes.
03
How is this different from our QMS?
Your QMS captures signatures against documents. Kalypsis captures them against the regulation itself — at the citation level — and can prove it. It runs alongside platforms like Veeva or MasterControl; it doesn't replace them.
04
Do we still need a consultant or CRO?
For interpretation-heavy strategy, maybe. For knowing what applies to you, tracking changes, and proving reviews — the work that fills most consulting invoices — no. Kalypsis is built for teams at the stage before they can afford either.
05
What does "tamper-evident" mean in practice?
Every obligation, review, and change is cryptographically sealed and chained to what came before. If any record is altered after the fact, the chain breaks visibly — so your evidence is verifiable by auditors, not just asserted.
06
How do we get started?
Book a free demo. Onboarding starts with your org profile — device class, stage, quality system — and you'll see your computed obligation set the same day.
01
What does Kalypsis actually do?
Kalypsis computes which FDA regulations apply to your organization, monitors them for change continuously, and binds every compliance review to the exact regulatory text — producing a tamper-evident audit trail you can hand to an inspector. Think Vanta, but for the FDA.
02
How much does an FDA gap analysis normally cost?
A consultant-led gap analysis typically runs $15K–$40K, takes 6–12 weeks, and starts going stale the day it's delivered. Kalypsis computes yours from your org profile in minutes and keeps it current as the CFR changes.
03
How is this different from our QMS?
Your QMS captures signatures against documents. Kalypsis captures them against the regulation itself — at the citation level — and can prove it. It runs alongside platforms like Veeva or MasterControl; it doesn't replace them.
04
Do we still need a consultant or CRO?
For interpretation-heavy strategy, maybe. For knowing what applies to you, tracking changes, and proving reviews — the work that fills most consulting invoices — no. Kalypsis is built for teams at the stage before they can afford either.
05
What does "tamper-evident" mean in practice?
Every obligation, review, and change is cryptographically sealed and chained to what came before. If any record is altered after the fact, the chain breaks visibly — so your evidence is verifiable by auditors, not just asserted.
06
How do we get started?
Book a free demo. Onboarding starts with your org profile — device class, stage, quality system — and you'll see your computed obligation set the same day.
Build your FDA Trust Center.
Know your obligations, generate evidence automatically, and stay continuously audit-ready.
Build your FDA Trust Center.
Know your obligations, generate evidence automatically, and stay continuously audit-ready.