EU MDR Consultants

Consultants for the EU Medical Device Regulation (2017/745): classification, technical documentation, notified body audits and CE marking under the MDR.

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Name	Type	Country	Specialties
AA Alive Medical Device Consulting	Company	Malaysia	EU MDR, FDA
AARQK Consulting	Company	Netherlands	EU MDR, IVDR, Clinical Evaluation
Accumed	Company	Switzerland	EU MDR, IVDR
Acorn Regulatory	Company	Ireland	EU MDR, IVDR
ADAX	Company	Slovenia	EU MDR, Clinical Evaluation
Advena Ltd	Company	Malta	EU MDR, IVDR
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
Archer Research	Company	Belgium	EU MDR, IVDR, Clinical Evaluation
ARQon	Company	Singapore	EU MDR, IVDR, FDA, Clinical Evaluation
Billev Pharma East	Company	Slovenia	EU MDR, IVDR, Clinical Evaluation
Biochem Consulting	Company	Italy	EU MDR, IVDR, Clinical Evaluation
Boulder iQ	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation
Cattaneo Medical Consulting	Individual	Italy	EU MDR
CliniExperts	Company	India	EU MDR, IVDR, Clinical Evaluation
Clinres Farmacija	Company	Slovenia	EU MDR, IVDR, Clinical Evaluation
CMC Medical Devices	Company	Spain	EU MDR, IVDR
CMS SciDoc	Company	Australia	EU MDR, FDA, Clinical Evaluation
Congenius	Company	Switzerland	EU MDR, 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
Decomplix	Company	Switzerland	EU MDR, IVDR
Device Quality	Individual	Ireland	EU MDR, FDA
DevicePharm Consultancy	Company	United Kingdom	EU MDR, IVDR
DM Experts	Company	France	EU MDR, IVDR, Clinical Evaluation, Cybersecurity
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
EAP MedTech Consulting	Company	Malaysia	EU MDR
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
EUMEDIQ	Company	Switzerland	EU MDR, IVDR, Clinical Evaluation, Cybersecurity
GBA Key2Compliance	Company	Sweden	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
Hands on Research	Company	United Kingdom	EU MDR, Clinical Evaluation
I3CGlobal	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
Iberania	Company	Spain	EU MDR, IVDR, Clinical Evaluation
IMed Consultancy	Company	United Kingdom	EU MDR, IVDR
ipp. Dr. Klügl	Company	Germany	EU MDR, Clinical Evaluation
ISOFAC Group	Company	France	EU MDR
Isotop	Individual	France	EU MDR, IVDR, FDA
Johner Institute	Company	Germany	EU MDR, IVDR, FDA
Kahlity	Company	Switzerland	EU MDR
Karkinen Consulting	Individual	Finland	EU MDR, FDA
KD&A	Company	Australia	EU MDR, FDA
Mansour Consulting LLC	Individual	United States	FDA, EU MDR, IVDR
MCRA	Company	United States	FDA, EU MDR, Clinical Evaluation, Cybersecurity
MDProject	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
MDR Consulting Group	Company	Greece	EU MDR, IVDR
MDR-Consulting	Individual	Germany	EU MDR
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
Medaptivo	Company	United Kingdom	EU MDR, Clinical Evaluation
Medecon	Company	Poland	EU MDR
MEDIcept	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation
Medicoforum	Company	Germany	EU MDR, Clinical Evaluation
Medifina	Company	Austria	EU MDR, IVDR
Medinex	Company	Netherlands	EU MDR, IVDR, Cybersecurity
MediNova	Company	Australia	EU MDR, FDA
Medixion	Company	Netherlands	EU MDR, Clinical Evaluation
Medos	Company	Sweden	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
Medotec	Company	Sweden	EU MDR, IVDR, Clinical Evaluation
Meliora Compliance	Individual	Czechia	EU MDR, FDA
Metecon	Company	Germany	EU MDR, IVDR, Clinical Evaluation, Cybersecurity
MethodSense	Company	United States	FDA, EU MDR, Cybersecurity
MiBB Regulatory	Individual	Denmark	EU MDR, Clinical Evaluation, Cybersecurity
Morulaa HealthTech	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
MT Promedt Consulting	Company	Germany	EU MDR, IVDR
NAMSA	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation, Cybersecurity
NEMIUS Medical Europe	Company	Germany	EU MDR, IVDR
Netherlands Consulting Group	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
Nexialist	Company	France	EU MDR, IVDR, Clinical Evaluation
NoBoVersum	Company	Hungary	EU MDR, IVDR, Clinical Evaluation
NordMDR	Company	Sweden	EU MDR, IVDR
NorMed Consulting	Company	Denmark	EU MDR, IVDR, FDA, Clinical Evaluation
NPD Consultants	Company	United Kingdom	EU MDR
NQSC	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
Obelis Group	Company	Belgium	EU MDR, IVDR, FDA
Operon Strategist	Company	India	EU MDR, IVDR, FDA, Clinical Evaluation
ORAVEC BIOMED	Company	Slovakia	EU MDR, IVDR, 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
PRSG Pharmaceutical and Regulatory Services	Company	Austria	EU MDR, IVDR
punktum	Company	Germany	EU MDR
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
RCF Consulting	Individual	United Kingdom	EU MDR, FDA, Clinical Evaluation
RegPak BioPharma Consulting	Company	Romania	EU MDR, IVDR, Clinical Evaluation
Regulatory Pathways Group	Company	United States	FDA, EU MDR
Regvo	Individual	United Kingdom	EU MDR, FDA
RQS - Roman Quality Support	Individual	Poland	EU MDR, IVDR
Sander Consult	Individual	Denmark	EU MDR
Scandinavian Regulatory Services	Company	Sweden	EU MDR, IVDR, FDA
SciMed Consultancy	Company	United Kingdom	EU MDR, IVDR, Clinical Evaluation
SeerPharma	Company	Australia	EU MDR, IVDR, FDA
seleon	Company	Germany	EU MDR, IVDR, Clinical Evaluation, Cybersecurity
Sequence Group LLC	Company	United States	FDA, EU MDR
SereniHealth	Company	United Kingdom	EU MDR, IVDR
SIFo Medical	Company	Austria	EU MDR, FDA
Silurus Software	Company	Hungary	EU MDR, FDA, Cybersecurity
SMEDTEC	Company	United Kingdom	EU MDR, IVDR, FDA
SpringRA	Company	Canada	FDA, EU MDR, Clinical Evaluation
St John Lynch & Co	Individual	Ireland	EU MDR, IVDR, Cybersecurity
Swiss MPC	Company	Switzerland	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
Tecno-Med Ingenieros	Company	Spain	EU MDR, IVDR
TGMed	Company	Slovakia	EU MDR, IVDR, FDA, Clinical Evaluation
The Jans Group LLC	Individual	United States	FDA, EU MDR
Thema	Company	Italy	EU MDR, IVDR
Tiina Tyni	Individual	Finland	EU MDR, FDA, Clinical Evaluation
Unihelp	Company	Greece	EU MDR, IVDR
Unitron Regulatory	Company	Netherlands	EU MDR, IVDR, FDA
Vantage MedTech	Company	United States	FDA, EU MDR, Clinical Evaluation
Vesta Consulting	Company	South Africa	EU MDR
White Lamb Consulting	Individual	United States	FDA, EU MDR, IVDR

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