Your QMS,
made to hold up
under any scrutiny.
We go beyond diagnosis. Starting from a data-driven Profiling, we work through your quality management system end to end – procedures, instructions, artefacts, team knowledge – and hand you a roadmap that makes you audit-ready at any point in time.
How We Engage
From Profiling to a plan you can execute
Every consulting engagement starts where the data leads. The Profiling service gives us an objective baseline – what the outside world sees, where the signals cluster. From there, we go inside: your procedures, your work instructions, your actual artefacts.
We listen to what your team already knows, identify the problems they cannot solve alone, and then we do the work – writing, revising, training, aligning. Not just advice. Hands-on delivery.
Profiling baseline
AI-powered analysis of external signals establishes an unbiased view of your regulatory standing and quality reputation before any internal review begins.
QMS deep-dive
We review procedures, work instructions and existing artefacts against current regulatory requirements and against what your team tells us is actually happening in practice.
Gap analysis & problem mapping
Known problems without good solutions, undocumented workarounds, outdated artefacts – we surface everything and prioritise by risk and effort.
Hands-on remediation
We write, revise and restructure. Procedures that reflect how work actually flows. Instructions that people use. Artefacts that are consistent and complete.
Training & knowledge transfer
Your team understands not just the what, but the regulatory why behind every process. Knowledge that stays long after the engagement ends.
Roadmap handover
A prioritised, actionable roadmap with short-, medium- and long-term measures – owned by your team, executable without us.
Scope of Work
What we actually deliver
Procedure & Instruction Writing
We write or rewrite SOPs, work instructions and guidance documents that reflect real workflows, meet current regulatory requirements and are actually usable by the people who need them.
IArtefact Review & Remediation
We analyse your existing complaint files, CAPA records, field action documentation and periodic reports – identifying gaps, inconsistencies and audit vulnerabilities, then fixing them.
IITraining & Regulatory Background
Interactive training sessions that go beyond process steps. We explain the regulatory intent behind the requirements – MDR, FDA, MDR Annex XIV, ISO 13485 – so your team can make good decisions independently.
IIIProblem-Solving & Clean-Up
When a team knows something is wrong but cannot find the right solution, we bring the experience of having solved similar problems across dozens of companies worldwide. We do not just diagnose – we clean up.
IVQMS Architecture Review
We step back and look at the system as a whole: document hierarchy, process interactions, control points. Where the architecture itself is the source of problems, we redesign it.
VAuthority Discussions & Negotiation Support
Drawing on direct experience of regulatory authority interactions across the FDA, BfArM, TGA, Swissmedic and others – including complex recall negotiations, MDR discussions and corrective action commitments – we prepare your team for and, where needed, participate in authority conversations.
- Response strategy for authority queries and warning observations
- Preparation of position papers and corrective action plans
- Coaching for authority meetings and audit opening / closing sessions
- Post-inspection response drafting
The Deliverable
A roadmap that makes you
audit-ready at any point in time
The consulting engagement ends with a concrete, prioritised action plan – not a wish list. Three horizons, each with clear owners, effort estimates and success criteria. Built to be executed by your team, tracked in your systems.
Immediate actions
Address the highest-risk gaps and visible audit vulnerabilities before anything else. Fast wins that reduce exposure and demonstrate responsiveness.
- Close open artefact gaps in complaint and CAPA files
- Update overdue or non-compliant procedures
- Establish missing regulatory reportability logic
- Resolve any outstanding authority commitments
- Quick-reference training for front-line QMS users
Structural improvements
Rebuild the foundations that are causing recurring problems. Systematic changes that reduce the effort of staying compliant over time.
- Redesign core PMS procedures for workflow alignment
- Implement standard phrase libraries and document templates
- Establish consistent CAPA methodology and effectiveness checks
- Align field action and recall processes to all relevant jurisdictions
- Deep-dive training on regulatory background and intent
Sustainable excellence
Move from reactive compliance to a proactive quality culture. The QMS becomes a genuine operational advantage, not an administrative burden.
- Continuous signal monitoring and trend analysis
- Integrated change control and product feedback loops
- Automated periodic report generation from live data
- Cross-functional quality governance structures
- Ongoing regulatory landscape monitoring and adaptation
„We do not hand you a report and leave.
We stay until the work is done and your team can carry it forward.“
Manage Complexity · Consulting Promise
Why It Matters
Experience you cannot simulate
Post market surveillance looks straightforward on paper. In practice, it is one of the most operationally demanding areas of medical device compliance – and one of the most consequential when it goes wrong.
Our consulting is grounded in the realities of having managed more than 200 recalls across multiple jurisdictions, processed over 30,000 complaints, negotiated with regulatory authorities worldwide and built PMS systems that held up under the hardest scrutiny.
We know what good looks like because we have seen it fail, been held accountable for it, and rebuilt it from the ground up.
Start the Conversation
Tell us where your QMS stands today
A first call costs nothing and tells you a great deal. We listen, ask the right questions, and tell you honestly what kind of engagement would actually help.