FDA Regulatory Consultants

Consultants for FDA medical device regulation: regulatory strategy, pre-submissions, 510(k) and De Novo pathways, and QSR / QMSR compliance.

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Name	Type	Country	Specialties
AA Alive Medical Device Consulting	Company	Malaysia	EU MDR, FDA
ADB Consulting & CRO	Individual	United States	FDA, Cybersecurity
Aegis Clinical Strategies	Individual	United Kingdom	EU MDR, FDA, Clinical Evaluation
AlvaMed	Company	United States	FDA, EU MDR
Ambit Iberia	Company	Spain	EU MDR, IVDR, FDA, Clinical Evaluation
Arora 297 Consultancy	Company	Canada	FDA
ARQon	Company	Singapore	EU MDR, IVDR, FDA, Clinical Evaluation
Arthroplasty Regulatory Consulting	Individual	United States	FDA
BioDesign Regulatory Services	Individual	United States	FDA
Biologics Consulting	Company	United States	FDA
Boulder iQ	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation
CardioMed Device Consultants	Company	United States	FDA
CMS SciDoc	Company	Australia	EU MDR, FDA, Clinical Evaluation
CQURA	Company	United Kingdom	EU MDR, IVDR, FDA, Clinical Evaluation
Credas	Company	Singapore	EU MDR, IVDR, FDA, Clinical Evaluation
Critical Catalyst	Company	Portugal	EU MDR, IVDR, FDA, Clinical Evaluation
CS-Tran	Company	Norway	EU MDR, FDA, Clinical Evaluation
Cyon Medical	Company	Australia	EU MDR, FDA
Device Quality	Individual	Ireland	EU MDR, FDA
dicentra	Company	Canada	FDA
Donawa Lifescience Consulting	Company	Italy	EU MDR, FDA, Clinical Evaluation
DP Distribution & Consulting LLC	Company	United States	FDA, EU MDR, IVDR
Dr. Grömping Consulting	Individual	Germany	EU MDR, IVDR, FDA, Clinical Evaluation
Drua Consulting	Individual	United States	FDA, EU MDR
DuVal & Associates	Company	United States	FDA
Eisner Safety Consultants	Individual	United States	FDA, EU MDR
Elevate MedTech	Company	New Zealand	EU MDR, IVDR, FDA, Cybersecurity
Emergo by UL	Company	United States	FDA, EU MDR, IVDR
en.co.tec Schmid KG	Company	Austria	EU MDR, IVDR, FDA, Clinical Evaluation
F&R Solutions	Individual	Canada	FDA
GBA Key2Compliance	Company	Sweden	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
I3CGlobal	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
INGENES LLC	Company	United States	FDA
Innolitics	Company	United States	FDA, Cybersecurity
ISOplan USA	Company	United States	FDA
Isotop	Individual	France	EU MDR, IVDR, FDA
Jessica Mu Consulting LLC	Individual	United States	FDA
Johner Institute	Company	Germany	EU MDR, IVDR, FDA
Karkinen Consulting	Individual	Finland	EU MDR, FDA
KD&A	Company	Australia	EU MDR, FDA
Lighthouse Regulatory Consulting	Individual	United States	FDA
Lucent Clinical Consulting LLC	Individual	United States	FDA
Mansour Consulting LLC	Individual	United States	FDA, EU MDR, IVDR
MCRA	Company	United States	FDA, EU MDR, Clinical Evaluation, Cybersecurity
mdi Consultants	Company	United States	FDA
MDProject	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
MDRC	Company	Slovakia	EU MDR, FDA, Clinical Evaluation
MDS Denmark	Company	Denmark	EU MDR, FDA, Clinical Evaluation
MDS Finland	Company	Finland	EU MDR, Clinical Evaluation, FDA
Med-Di-Dia	Company	Ireland	EU MDR, IVDR, FDA, Clinical Evaluation
Medical Device Academy	Company	United States	FDA
MEDIcept	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation
MediNova	Company	Australia	EU MDR, FDA
Medos	Company	Sweden	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
Meliora Compliance	Individual	Czechia	EU MDR, FDA
MethodSense	Company	United States	FDA, EU MDR, Cybersecurity
Morulaa HealthTech	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
Mtech Group	Company	United States	FDA
NAMSA	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation, Cybersecurity
Netherlands Consulting Group	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
NorMed Consulting	Company	Denmark	EU MDR, IVDR, FDA, Clinical Evaluation
NovaReg Regulatory Consulting	Company	Australia	IVDR, FDA
NQSC	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
Nu Device Consulting LLC	Individual	United States	FDA
Obelis Group	Company	Belgium	EU MDR, IVDR, FDA
Operon Strategist	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
Panabistics	Company	Canada	FDA, EU MDR
Patient Guard	Company	United Kingdom	EU MDR, IVDR, FDA, Clinical Evaluation
Practical RA	Company	Australia	EU MDR, IVDR, FDA, Clinical Evaluation
Prime Path Medtech	Company	United States	FDA
ProMedic	Company	United States	FDA
QARA Consulting	Company	Sweden	EU MDR, IVDR, FDA, Clinical Evaluation
QbD Group	Company	Belgium	EU MDR, IVDR, FDA, Clinical Evaluation
QLE Group	Company	Belgium	EU MDR, IVDR, FDA
QMSPro Consulting	Individual	Denmark	EU MDR, FDA
QRA Medical	Company	United Kingdom	EU MDR, IVDR, FDA, Clinical Evaluation
QReg	Company	United Kingdom	EU MDR, FDA, Clinical Evaluation
Qserve Group	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
QualiFest	Individual	Belgium	EU MDR, FDA
Quality Commercial Consultants	Company	United States	FDA, EU MDR, Cybersecurity
Quality Smart Solutions	Company	Canada	FDA
Qualtech Japan Consulting Corporation	Company	Japan	FDA, Clinical Evaluation
RCF Consulting	Individual	United Kingdom	EU MDR, FDA, Clinical Evaluation
Regulatory Pathways Group	Company	United States	FDA, EU MDR
Regvo	Individual	United Kingdom	EU MDR, FDA
RQM+	Company	United States	FDA
Sanrubio Medical Devices Consulting	Company	United States	FDA
Scandinavian Regulatory Services	Company	Sweden	EU MDR, IVDR, FDA
SeerPharma	Company	Australia	EU MDR, IVDR, FDA
Sequence Group LLC	Company	United States	FDA, EU MDR
SIFo Medical	Company	Austria	EU MDR, FDA
Silurus Software	Company	Hungary	EU MDR, FDA, Cybersecurity
SMEDTEC	Company	United Kingdom	EU MDR, IVDR, FDA
Smith Associates	Company	United States	FDA
SoftwareCPR	Company	United States	FDA, Cybersecurity
SpringRA	Company	Canada	FDA, EU MDR, Clinical Evaluation
Swiss MPC	Company	Switzerland	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
TGMed	Company	Slovakia	EU MDR, IVDR, FDA, Clinical Evaluation
The Jans Group LLC	Individual	United States	FDA, EU MDR
Tiina Tyni	Individual	Finland	EU MDR, FDA, Clinical Evaluation
U Care Unlimited LLC	Company	United States	FDA
Unitron Regulatory	Company	Netherlands	EU MDR, IVDR, FDA
Vantage MedTech	Company	United States	FDA, EU MDR, Clinical Evaluation
White Lamb Consulting	Individual	United States	FDA, EU MDR, IVDR

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