Quality · Compliance · Trust
Global quality and risk expertise, delivered like concierge service.
Global Quality Concierge gives medical device, IVD, pharma, biotech, and regulated manufacturing teams a single, trusted partner for risk management, post-market surveillance, and audit-ready compliance — anywhere your products are sold, with the responsiveness of an in-house team.
Meet Your Concierge
One consultant. One name behind every engagement.
Global Quality Concierge is led personally by its founder — no rotating bench, no account handoffs.
Quality driven.
Future focused.
Jayet Moon
Founder & Principal Consultant, Global Quality Concierge
Jayet is a quality and risk management authority with a master's degree in biomedical engineering from Drexel University. He is a Senior member of ASQ, holding the CQE, CSQP, and CQIA certifications, a Chartered Quality Professional in the U.K. (CQP-MCQI), a PMI Certified Risk Management Professional (PMI-RMP), and an ISO 13485 & ISO 9001 Lead Auditor.
He is the author of several books on quality and risk management published by ASQ Quality Press and other imprints, and a regular contributor to Outsourced Pharma and MedDevice Online. Every GQC engagement is led directly by Jayet — the same rigor and evidence-based discipline behind his published work, applied to your risk file, your audit, and your program.
John F. Kennedy · Rice University · 1962 Jayet & GQC's Moonshot Standard
"But why, some say, the Moon? Why choose this as our goal? And they may well ask, why climb the highest mountain? Why, 35 years ago, fly the Atlantic? We choose to go to the Moon. We chose to go to the Moon. We choose to go to the Moon in this decade and do the other things, not because they are easy, but because they are hard; because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we're willing to accept."
— John F. Kennedy, Rice University, September 12, 1962
Seven years later, on July 20, 1969, Apollo 11 delivered on that challenge: Neil Armstrong and Buzz Aldrin became the first humans to walk on the Moon while Michael Collins piloted the command module Columbia in lunar orbit above them — a decade-long goal, set out plainly and hard, met on schedule. It's the standard we hold our own work to: name the hard goal, then do what it takes to earn it.
Services
Concierge-level expertise across the full compliance lifecycle.
Four practice areas, one dedicated point of contact. Every engagement is staffed by a senior consultant who owns your file from first call to final sign-off.
01 — Risk Management
ISO 14971 & ICH Q9 Risk Management
We build, complete, and take ownership of your Risk Management Files — hazard analysis, FMEA facilitation, and risk-benefit rationale that holds up under any notified body or FDA review, wherever your submission is headed.
- ISO 14971 risk management programs
- ICH Q9 quality risk management
- Risk file remediation & gap closure
- FDA / IEC 62366 usability risk remediation
- Complete Risk Management File ownership
02 — Post-Market
Post-Market Surveillance & Signal Intelligence
We stand up complaint trending, signal detection, and PMSR/PSUR authoring that keeps pace with your install base — and gives you the evidence trail regulators expect to see, in every market you serve.
- PMSR & PSUR authoring
- CAPA & complaint intelligence
- Trending & signal detection
- PMCF planning & reporting
03 — Remediation
Regulatory Remediation & Audit Readiness
From an FDA 483 to a notified body finding, our team steps in fast — building the response, the CAPA plan, and the evidence file your inspectors expect. We communicate directly with FDA on your behalf to drive every finding to resolution.
- FDA 483 & warning letter remediation
- Notified body finding management
- ISO 9001 & ISO 13485 audit support
- Supplier quality & audit readiness
- Direct FDA correspondence & resolution management
04 — Systems
Cybersecurity, DHF & Quality Systems
We help you build design assurance, technical files, and cybersecurity risk programs aligned to ISO 27001 and current premarket cybersecurity expectations — plus the QMS infrastructure to keep it all running, globally.
- ISO 27001 cybersecurity risk management
- Design assurance / DHF / technical files
- Remote QMS implementation & maintenance
- Fractional quality & risk leadership
Legal expert witness engagements and product failure investigation support are also available on request.
Approach
White-glove service. Global regulatory reach.
Global Quality Concierge exists to make world-class quality and regulatory expertise as accessible as a phone call — anywhere your products are sold, anywhere your team needs support.
Concierge response
A senior consultant, not a call center. Every engagement gets a dedicated lead who knows your file inside out and is reachable within 24 hours, every time.
Global regulatory fluency
FDA, EU MDR/IVDR, ISO, Health Canada, TGA, PMDA — we translate compliance requirements across every market your products touch.
Evidence-based, audit-ready
Every recommendation is traceable, defensible, and built to hold up under inspection. Data first, opinions second.
Full ownership, not just advice
We complete your Risk Management Files and take ownership of outsourced risk management processes end to end — project-based support or fractional leadership, scaled to what your team needs.
Compliance
Structured governance for medical devices, IVD, pharma, and biotech.
We help regulated organizations manage end-to-end quality and risk workflows — structured, traceable, and ready for inspection on any given day, in any market you operate.
- ISO 14971 and ICH Q9-aligned risk management programs
- FDA 483, warning letter, and notified body remediation tracking
- Complaint handling, CAPA governance, and supplier quality oversight
- Cybersecurity risk management aligned to ISO 27001
- ISO 9001 and ISO 13485 audit programs, wherever you're certified
- Remote QMS implementation and maintenance
- Fractional quality and compliance leadership
- Legal expert witness and product failure investigation support
Our Commitment
Structured compliance solutions for medical devices, IVD, pharma, and biotech.
One dedicated consultant
You get a named lead, not a rotating roster — someone who carries context from your first call onward.
24-hour response, always
Every inquiry gets a substantive reply from a senior consultant within one business day.
Evidence you can defend
Files, trending, and rationale built to survive scrutiny from any regulator, anywhere — and when it counts, we communicate directly with FDA on your behalf to drive findings to resolution.
Articles
Insights & industry commentary.
Jayet is a regular contributor to leading industry publications, translating evolving regulatory expectations into practical guidance for quality and risk teams.
Column
Outsourced Pharma
Commentary on quality, risk, and outsourcing strategy across the pharmaceutical supply chain.
Read contributions ↗Column
MedDevice Online
Perspectives on medical device risk management, post-market surveillance, and regulatory readiness.
Read contributions ↗Books
Published Works
Six books on quality, risk, cybersecurity, and AI fundamentals — published by ASQ Quality Press and others.
Browse the shelf ↗Bring concierge-level care to quality and compliance.
Tell us where you need support — risk management, post-market surveillance, cybersecurity governance, audit remediation, or ongoing quality leadership — and a senior consultant will follow up within 24 hours.
Contact UsContact
Contact Our Experts
Submit your request below and one of our senior quality and compliance consultants will follow up with you within 24 hours.
Response
Within one business day, every time
Coverage
North America · EU · UK · APAC