IVDR Consultants

Consultants for the EU In Vitro Diagnostic Regulation (2017/746): IVD classification, performance evaluation and technical documentation under the IVDR.

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Name	Type	Country	Specialties
AARQK Consulting	Company	Netherlands	EU MDR, IVDR, Clinical Evaluation
Accumed	Company	Switzerland	EU MDR, IVDR
Acorn Regulatory	Company	Ireland	EU MDR, IVDR
Advena Ltd	Company	Malta	EU MDR, IVDR
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
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
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
Decomplix	Company	Switzerland	EU MDR, IVDR
DevicePharm Consultancy	Company	United Kingdom	EU MDR, IVDR
DM Experts	Company	France	EU MDR, IVDR, Clinical Evaluation, Cybersecurity
DP Distribution & Consulting LLC	Company	United States	FDA, EU MDR, IVDR
Dr. Grömping Consulting	Individual	Germany	EU MDR, IVDR, FDA, Clinical Evaluation
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
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
Isotop	Individual	France	EU MDR, IVDR, FDA
Johner Institute	Company	Germany	EU MDR, IVDR, FDA
Mansour Consulting LLC	Individual	United States	FDA, EU MDR, IVDR
MDProject	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
MDR Consulting Group	Company	Greece	EU MDR, IVDR
Med-Di-Dia	Company	Ireland	EU MDR, IVDR, FDA, Clinical Evaluation
MEDIcept	Company	United States	FDA, EU MDR, IVDR, Clinical Evaluation
Medifina	Company	Austria	EU MDR, IVDR
Medinex	Company	Netherlands	EU MDR, IVDR, Cybersecurity
Medos	Company	Sweden	EU MDR, IVDR, FDA, Clinical Evaluation, Cybersecurity
Medotec	Company	Sweden	EU MDR, IVDR, Clinical Evaluation
Metecon	Company	Germany	EU MDR, IVDR, 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
NovaReg Regulatory Consulting	Company	Australia	IVDR, FDA
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
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
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
QRA Medical	Company	United Kingdom	EU MDR, IVDR, FDA, Clinical Evaluation
Qserve Group	Company	Netherlands	EU MDR, IVDR, FDA, Clinical Evaluation
RegPak BioPharma Consulting	Company	Romania	EU MDR, IVDR, Clinical Evaluation
RQS - Roman Quality Support	Individual	Poland	EU MDR, IVDR
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
SereniHealth	Company	United Kingdom	EU MDR, IVDR
SMEDTEC	Company	United Kingdom	EU MDR, IVDR, FDA
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
Thema	Company	Italy	EU MDR, IVDR
Unihelp	Company	Greece	EU MDR, IVDR
Unitron Regulatory	Company	Netherlands	EU MDR, IVDR, FDA
White Lamb Consulting	Individual	United States	FDA, EU MDR, IVDR

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