Protect market
access
Build the readiness and objective evidence to withstand FDA inspections, notified-body audits, and post-market scrutiny.
Schedule a callMedical device quality, regulatory & transaction advisory
Turn quality complexity into confident execution.
Clavis ProSynergy helps medical-device executives protect market access, strengthen enterprise value, and move through inspections, remediation, commercialization, and due diligence with confidence. We turn complex quality and regulatory challenges into systems that work, evidence that holds, and teams that perform.
Quality systemsRisk managementInspection readinessDue diligence
1Analyze2Evaluate3Control4Residual Risk5Review6Monitor
Quality system architecture Risk-integrated
Executive value
Quality decisions in business terms.
The executive question is not simply whether the system is compliant. It is whether the organization can see risk early, act decisively, and demonstrate control when market access, revenue, or enterprise value is on the line.
Protect market
Support commercial continuity
Create quality architecture that can scale through launch, growth, supply pressure, and organizational change without becoming the constraint.
Preserve enterprise value
Make product risk, quality performance, and operational control visible and defensible for investors, partners, boards, and transactions.
Improve executive control
Translate regulatory complexity into clear priorities, ownership, metrics, escalation paths, and decisions leadership can act on.
35+Years in medtech quality leadership
40+FDA inspections & notified-body audits
20+Quality systems transformed or remediated
100+Class II & III devices supported
Expertise
Strategy embedded in action.
We pair executive-level perspective with hands-on implementation—because durable compliance is built in the operating system, not the slide deck.
Quality system transformation
Turn fragmented procedures and uneven execution into a connected, scalable quality system that people can actually use.
Inspection & audit readiness
Build the evidence, confidence, and organizational fluency needed to meet regulators and notified bodies with clarity.
Risk management integration
Connect product risk, post-market signals, CAPA, clinical evidence, and quality decisions into one defensible system.
Design & technical documentation
Create a clear line from requirements and design evidence to the technical documentation that demonstrates control.
Digital QMS implementation
Translate real quality processes into digital workflows that improve adoption, visibility, and operating discipline.
Executive quality
strategy
Give leadership a practical roadmap that aligns compliance priorities, resources, risk, and business objectives.
Our approach
Reveal the structure.
Build the capability.
Clavis means key. Our work is designed to unlock the underlying structure of a challenge, so the path forward becomes visible and executable.
Reveal
See the system as it really operates—across procedures, people, records, risks, and interfaces.
Structure
Turn complexity into a practical architecture with clear ownership, sequence, and decision points.
Execute
Move from assessment to implementation with focused actions, measurable progress, and embedded capability.
Prove
Build the evidence and organizational confidence to demonstrate that the system works consistently.
ClarityKnow what matters
EfficiencyFocus the work
ConfidenceProve the system
Our philosophy
Quality is strategic
cost avoidance.
Quality is not simply a compliance function. Done well, it protects revenue, preserves market access, strengthens enterprise value, and gives teams the confidence to move faster.
Clavis helps leaders move beyond compliance theater by finding the system patterns beneath recurring issues—and building quality architecture that works under real-world conditions.
Build quality systems that strengthen daily operations and withstand regulatory scrutiny.
Build strength before the stakes rise.
Design inspection-ready systems, risk-based governance, and operating discipline before a launch, acquisition, audit, or period of rapid growth.
- QMSR & ISO 13485 alignment
- Inspection-ready infrastructure
- Risk-based governance & metrics
Respond decisively when risk is real.
Mobilize experienced operators to address serious findings, restore control, and lead the work through reinspection or recertification.
- FDA 483 & warning-letter response
- Notified Body findings
- Remediation & reinspection leadership
Where we add value
Built for pivotal moments.
The moments with the most at stake rarely arrive neatly packaged. We bring the perspective and structure to help your organization move decisively.
- Scaling from development into commercialization
- Preparing for an FDA inspection or notified-body audit
- Recovering from audit findings or systemic quality issues
- Integrating quality operations after rapid growth or change
- Modernizing an eQMS without losing the real process
- Building transaction-ready quality and regulatory evidence
Why Clavis ProSynergy
Senior expertise, assembled around the opportunity.
Clavis is a networked specialist firm. Lance leads each engagement and assembles the precise mix of former regulators, quality-system architects, operational leaders, and technical specialists the work demands.
Operational
leadership
We translate recommendations into resourced plans, lead workstreams with your teams, and measure progress against real regulatory and commercial outcomes.
Regulatory + business fluency
Every decision is viewed through both lenses: what satisfies the regulator and what protects market access, supply continuity, valuation, and growth.
Right-sized
senior teams
Engagements are built around the issue, technology, and geography—giving clients direct access to experienced operators without layers of generalists.
Former regulatorsQuality-system architectsOperational leadersTechnical specialists
FOUNDER - Lance Mattoon
Leadership
Senior perspective.
Hands-on partnership.
Lance Mattoon is a career medtech operator who has spent more than 35 years building, leading, and remediating quality systems.
His career spans engineering, manufacturing, corporate quality systems, development quality, operations quality, and division-level executive leadership across startups and global manufacturers. The teams he has led have supported more than 100 Class II and III devices across cardiovascular, renal, neuromodulation, imaging, and implantable technologies.
That range gives Lance a practical view of how quality architecture, organizational design, and day-to-day operations interact—and why sustainable change must connect the boardroom to the work itself.
Managed 40+ FDA inspections and notified-body audits—front room and back room—while transforming or remediating 20+ quality systems, including 483 corrections and warning letter clearances that protected significant downstream commercial value.
35+Years in medtech quality
16Companies served from startup to global scale
100+Class II & III devices supported
LM
Lance MattoonPresident & Founder
Start a conversation
Bring us the complexity,
we’ll deliver the clarity.
In a focused introductory conversation, we’ll clarify the challenge, identify the highest-leverage starting point, and determine whether Clavis is the right partner.
When the stakes are high
- 01Clear decisions
- 02Controlled execution
- 03Defensible results
Speak directly with Lance.
(925) 397-2787Call Clavis ProSynergyFounder-led from the first conversation through execution