Your Quality Team, On Retainer
Embedded quality and regulatory support: ongoing, on call, without the headcount.
The Challenge
Most manufacturers feel the gap not in a crisis, but in the quiet weeks, when the quality system needs an owner and there isn't one.
A QMS Without an Owner
Your quality lead just left, so who owns the QMS now? The system still needs a steady hand long before you can hire a replacement.
Compliance Outpaced by Growth
Production is scaling faster than your compliance function? New lines, new suppliers and new markets all add quality obligations your current team cannot absorb alone.
Always Reactive, Never Ready
Every audit catches you reactive instead of already ready? Without continuous upkeep, each inspection becomes a project rather than a formality.
The VigilaMed Solution
Embedded Quality, On Your Terms
We become an extension of your team: a named consultant who knows your quality system, your products and your regulators, and who keeps the whole thing audit-ready between projects. You get senior QARA capacity on retainer, scaled to what you actually need, without carrying a full-time headcount.
Manufacturing-First Methodology: We embed within your production reality rather than bolting compliance on top of it. Every recommendation is one your floor can actually run, so quality stays current without slowing the line.
The Quality Functions We Run
Embedded means accountable for the day-to-day work, not just available for advice. These are the quality functions we run, grouped the way our services are. On each one, we either own the function end to end or maintain it while your team runs it, scaled to what you need.
Quality Systems & Compliance
The core infrastructure, kept live.
- Document and record control
- NCR management
- CAPA ownership
- Change control
- Ongoing gap monitoring
Audit Readiness & Operations
Always ready, never rebuilt.
- Internal audits
- Supplier and vendor audits
- Management review inputs
- Continuous audit-readiness
Post-Market & Regulatory Operations
Surveillance that stays current.
- Complaint handling
- Vigilance and adverse-event reporting
- PMS upkeep
- Trend analysis
- Training records
Two kinds of work, kept deliberately separate.
Continuous: included in your retainer
The month-to-month run and upkeep of these functions. Steady senior oversight, maintained as part of your agreed capacity.
Scoped when it spikes: a separate engagement
A major CAPA surge, a recall, a 483 response or a full QMS build is its own scoped project. Your retainer keeps these functions steady and escalates into project work when the moment calls for it, rather than absorbing it under a flat fee.
What You Get
Those functions come with a defined service level: a standing set of deliverables that keep your quality system current every month, not just before an audit.
- Named consultant: a single, accountable QARA lead who knows your systems
- Monthly QMS health check: catching drift before it becomes a finding
- Continuous audit-readiness: maintained between inspections, not rebuilt before them
- Priority response window: your queries answered ahead of project work
- On-call regulatory guidance: practical answers as questions arise
- Quarterly compliance review: a structured look back and a plan for the quarter ahead
Put simply, this is the engagement that means you never have the 2am audit panic again. A retainer simply formalises a relationship our clients already keep informally, and the proof is in who stays.
Client Retention Rate
Clients who engage us do not leave. The retainer makes that permanent.
Ovation Medical
Kenji Watabe, VP Operations. One project became an ongoing relationship.