Healthcare quality & regulatory consulting · Dallas, TX
Our support for your quality.
Even the most advanced companies and innovative products sometimes need some support. Our mission is to align your brilliant ideas with the global requirements.
Founded
April 2025
Headquarters
Dallas, Texas
Focus
Healthcare & life sciences
Who we are
A specialized partner for quality, regulatory and compliance in healthcare.
qteam service LLC provides highly specialized consulting services to the healthcare industry: management system support, process optimization and regulatory compliance assistance.
We work as an extension of your own team – hands-on, pragmatic and focused on results that hold up in front of auditors, authorities and customers.
What we do
Services that keep quality, compliance and business aligned.
From building your management system to supporting you through audits, transfers and acquisitions – we bring experienced hands exactly where you need them.
01
Management systems
Set-up and maintenance of quality, regulatory, risk and supplier management systems – built to fit your organization and to stand up to inspection.
02
Process & performance optimization
Leaner processes and measurable performance improvements that lower the cost of quality without compromising compliance.
03
Complaints & non-compliance
Structured handling of complaints and non-conformities, from investigation and root cause to effective, documented closure.
04
Qualification & validation
Practical support for qualification and validation activities for equipment, processes and systems.
05
Manufacturing transfer
Planning and execution support for moving manufacturing between sites or partners – on time and compliant.
06
M&A and relocations
Quality and regulatory support for mergers, acquisitions and site relocations, from due diligence to integration.
07
Audits
Audit preparation and internal audits, so your team is ready for notified bodies, authorities and customers.
08
Clinical information systems & reimbursement
Support for clinical information systems and reimbursement topics for providers and manufacturers.
Training & audit readiness
Be ready – before the auditor arrives.
qteam service LLC can also be booked for trainings and realistic audit simulations. We prepare your people and your organization for audits and inspections by authorities, notified bodies and customers – tailored to your quality system, your products and the regulations that apply to you.
01
Behavior training for audits & inspections
How to act when the auditor or inspector is in the room: answering questions accurately and to the point, presenting records with confidence, handling document requests and escalations, and working smoothly between front room and back room. Practical role plays for management, subject matter experts and operational staff.
02
Test audits before mock audits & inspections
A structured test audit ahead of your planned mock audit or inspection. We review your processes and records against the applicable requirements, identify gaps early and help you close them – so the mock audit confirms your readiness instead of revealing surprises.
03
Unannounced test audits
Would you pass if the inspector arrived today? Agreed with your management in advance, we perform unannounced test audits – without any audit or inspection scheduled – to show how ready your organization really is in daily operations.
Rapid response
Urgently needed, rapidly deployable support.
When product issues arise or a recall is on the table, time matters. We step in quickly to reinforce your existing internal specialists – so your team can stay focused while the critical work gets done.
Typical situations
- Product issues and recalls
- Peak workloads in quality and regulatory teams
- Audits and inspections on short notice
- Interim support for your internal specialist staff
Industries
Built for the healthcare ecosystem.
Our experience spans the full healthcare value chain – from those who develop and manufacture products to those who use them every day to save lives.
Life sciences
Research-driven organizations bringing new products to market.
Medical devices
Manufacturers navigating quality system and regulatory requirements.
Pharmaceuticals
Companies operating under demanding GMP and compliance expectations.
Hospitals
Care providers improving processes, systems and patient safety.
Emergency medical services
EMS organizations that need reliable processes under pressure.
Fire departments
First responders who depend on equipment, training and documentation.
About us
Experienced people. Transatlantic perspective.
qteam service LLC was founded in April 2025 in Dallas, Texas. We combine deep, hands-on experience in healthcare quality and regulatory affairs with a practical, solution-oriented way of working.
Together with our European partner, qteam service GmbH, we support clients on both sides of the Atlantic.
JB
Johanna C. Buettner
COO · Notary Public (TX)
Notary Public
Notary services in Dallas, Texas.
We also act as Notary Public, commissioned by the Texas Secretary of State. Notarizations are available by appointment only – no walk-ins.
Please note
I am not an attorney licensed to practice law in Texas and may not give legal advice or accept fees for legal advice.
Please bring a valid, government-issued photo ID and the unsigned document to your appointment.
Our first app
RangeLogger – robust record keeping for your sporting activities.
What hasn’t been recorded, hasn’t happened.
It is one of the key principles behind our quality work at qteam service LLC – and it should not stop at the workplace. RangeLogger brings the same robust, disciplined record keeping to your private, firearm-related sporting activities, so your records are complete, organized and at hand whenever you need them.
iPhone & iPad · iOS 17 or later · Mac with Apple silicon
RangeLogger
- Shooting sessions with ranges, shooters, firearms, ammunition, rounds, distances, wind, notes and photos
- Dry Fire, competition and malfunction & issue notes
- Firearm, ammunition and accessory inventory, plus license, insurance and range records
- License expiration reminders in your calendar
- Automatic iCloud sync across your devices, JSON backup and printed reports
- Optional App Lock with Face ID or Touch ID
Now available on the App Store. Paid download – no in-app purchases, no subscriptions, no ads.
Contact
Let’s talk about your next quality challenge.
Tell us briefly about your project or question – we will get back to you to arrange a conversation.
Address
qteam service LLC
13355 Noel Rd, Ste 1100
Dallas, TX 75240, USA
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