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The European Union Medical Device Regulation - Regulation (EU) 2017/745 (EU MDR)

The European Union Medical Device Regulation - Regulation (EU) 2017/745 (EU MDR)

Categories: Business, Business
Topics: eu mdr, eumdr, intended, intended meaning, mdr, regulation (eu) 2017/745 (eu mdr), the european union medical device regulation

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medical-device-regulation.eu

medical-device-regulation.eu medical-device-regulation.eu           
Keep Calm and start creating your MDR Transition Plan - Medical Device Regulation
Keep Calm and start creating your MDR Transition Plan Medical Device Regulation – MDR 2017/745 Consulting Service. With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR. KEY POINTS for a Smooth Transition: Planning, Reclassification, UDI […]


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Categories: Business/Healthcare, Health/Medicine, Business/Biotechnology and Pharmaceuticals, Business, Business
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decomplix.com

decomplix.com decomplix.com           
We Simplify Market Access for Medical Devices - Decomplix
Ensure 100% medical compliance. Decomplix does your CE certification for medical devices and IVD in the pre- and post-market phase. Learn more here.


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prisymid.com

prisymid.com prisymid.com           
Barcode Label Software and Artwork Management Solutions | Loftware
Barcode Label Software and Artwork Management Solutions | Loftware



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mdrivdr.com

mdrivdr.com mdrivdr.com           
MDR & IVDR EU Conference 2020 • MDR & IVDR EU Regulation Training
The MDR & IVDR EU Conference 2020 is dedicated to guidance and training for those impacted by the new Regulations to help you prepare to meet the timelines.


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qservegroup.com

qservegroup.com qservegroup.com           
Global Market Access for Medical Devices - Qserve Group
Qserve is your MedTech Consultant for Regulatory Affairs & Quality Assurance and Clinical Trials. Need regulatory advice, support or training? Contact us.


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regulatory-affairs.org

regulatory-affairs.org regulatory-affairs.org           
Dienstleistungspartner für Medizintechnikunternehmen - seleon GmbH
Die seleon GmbH ist seit 25 Jahren in Zentraleuropa ein führender Dienstleistungspartner für Medizintechnikunternehmen.


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regulatoryglobe.com

regulatoryglobe.com regulatoryglobe.com           
Regulatory Affairs for Medical Devices - EU MDR and IVDR
Regulatory Globe offers Expert Regulatory Affairs strategies and helpful implementation tools for medical devices. Stay updated with EU MDR, IVDR and more.


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med-cert.com

med-cert.com med-cert.com           
Medcert | MEDCERT ist Spezialist für die Zertifizierung von Medizinprodukten und QM-Systemen im Medizinbereich. Als eine der größten Benannten Stellen Deutschlands bieten wir außer CE-Kennzeichnung auch internationale Zulassungen für Medizinprodukte an.
Medcert | MEDCERT ist Spezialist für die Zertifizierung von Medizinprodukten und QM-Systemen im Medizinbereich. Als eine der größten Benannten Stellen Deutschlands bieten wir außer CE-Kennzeichnung auch internationale Zulassungen für Medizinprodukte an.


Moz DA: 16 Moz Rank: 3.4 Semrush Rank: 3,221,996
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johner-institute.com

johner-institute.com johner-institute.com           
Johner Institute - your regulatory partner
The Johner Institute supports medical device manufacturers in the standard-compliant and efficient development of their products and the establishment of QM systems through consulting, seminars, books and video trainings.


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easymedicaldevice.com

easymedicaldevice.com easymedicaldevice.com           
Home - Medical Device Regulation and ISO quality standard
Want to Master Medical Device Regulation & learn how to put a product on the market in Europe. Easy Medical Device is a platform for tools and resources for Regulatory Affairs, Quality Management, Regualtory Compliance. Learn how to choose your notified body or how the device regulation is different in other countries


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mdi-europa.com

mdi-europa.com mdi-europa.com           
mdi Europa | CE Marking "Made in Germany" for Medical Devices
Germany based EU Authorized Representative "mdi Europa" helps small to medium sized manufacturers to enter european medical device market.


Moz DA: 20 Moz Rank: 3.2 Semrush Rank: 4,716,991
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celegence.com

celegence.com celegence.com           
Life Sciences Regulatory Solutions & Services | Celegence
Celegence provides you with leading life sciences regulatory solutions & services for medical writing, medical device regulations, labeling, IDMP and more.


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orielstat.com

orielstat.com orielstat.com           
Oriel STAT A MATRIX | Medical Device Training, Consulting & Audits
Oriel STAT A MATRIX has been a global leader in medical device quality and regulatory training, consulting and auditing since 1968.


Moz DA: 31 Moz Rank: 4 Semrush Rank: 800,992
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medicaldeviceslegal.com

medicaldeviceslegal.com medicaldeviceslegal.com           
medicaldeviceslegal | Medical devices legal and regulatory blog
Medical devices legal and regulatory blog


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criterionedge.com

criterionedge.com criterionedge.com           
HOME - Criterion Edge
The Regulatory Writing Experts


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mantrasystems.co.uk

mantrasystems.co.uk mantrasystems.co.uk           
Medical Device Regulatory Consulting Services UK & EU MDR
Medical Device Regulatory Consulting Services. UK & EU MDR compliance for market access. Fully insured, ISO certified & TOPRA-registered consultants.


Moz DA: 9 Moz Rank: 2.1 Semrush Rank: 2,929,941 Facebook ♡: 632
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advenamedical.com

advenamedical.com advenamedical.com           
Advena UK Ltd - Medical Device and Cosmetics Consultancy
We are a specialist medical device regulatory consultancy offering a UK Responsible person service, support on regulatory affairs, cosmetics responsible person, quality management systems, and in-vitro diagnostic consultancy.


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regulatorypharmanet.com

regulatorypharmanet.com regulatorypharmanet.com           
Regulatory Pharma Net
Regulatory Pharma Net (RPN), founded in 1999, is a qualified Regulatory Affairs service and consulting company based in Italy. RPN highly-qualified team includes Regulatory Affairs, DrugDevelopment, Market Access and Pharmacovigilance Experts. RPN gives support during development, registration, launch and life cyclemanagement of Medicinal Products, Medical Devices, Cosmetics,Biocides and Food Supplements. RPN is partner of many pharmaceutical companies, managing hundredsof multitask projects, on a worldwide scale. We are proudly part of Pharos Healthcare Consulting, a new European Network of highly-specialised Market Access Strategic Consultancy. While maintaining each company’s independence and high local knowledge, we will be able to support Pharmaceutical companies in launching new drugs through our coordinated Market Access network across Europe, find out more at www.pharos-healthcare-consulting.com


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rimsys.io

rimsys.io rimsys.io           
The Only Holistic RIM Software for Medtech | Rimsys Regulatory Management Software
Learn about the first and only holistic Regulatory Information Management (RIM) software for medical device companies that consolidates all the functions of regulatory affairs.


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i3cglobal.com

i3cglobal.com i3cglobal.com           
World-Class Medical Device Regulatory Consulting Services
I3CGLOBAL is a vibrant and customer-focused company that provides medical device regulatory consulting services for US, EU & India.


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obelis.net

obelis.net obelis.net           
Your trusted partner for regulatory compliance
Explore our representation services for manufacturers exporting medical devices, in-vitro diagnostics, cosmetics, other products


Moz DA: 35 Moz Rank: 4 Semrush Rank: 1,524,551 Facebook ♡: 5
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emmainternational.com

emmainternational.com emmainternational.com           
Quality and Regulatory Consulting - EMMA International
EMMA International specializes in FDA regulatory affairs, compliance services, and submissions in the Life Sciences industry.


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maetrics.com

maetrics.com maetrics.com           



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namsa.com

namsa.com namsa.com           
NAMSA | Medical Device Contract Research Organization
The world's only 100% medical device-focused, full development Contract Research Organization (CRO). Learn how to accelerate your development program today!


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networkpartners.com

networkpartners.com networkpartners.com           



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treximo.com

treximo.com treximo.com           
Press Releases - ProPharma
Catch up on Press Releases and other special announcements about ProPharma and our subsidiaries.


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akrnconsulting.com

akrnconsulting.com akrnconsulting.com           
Medical Device CRO | AKRN Consulting | Contact our Experts
Experts in Clinical Research and Regulatory Services for MedTech and IVD Industry. Optimize your clinical trials with AKRN Medical Device CRO.


Moz DA: 7 Moz Rank: 1.4 Semrush Rank: 11,609,478 Facebook ♡: 30
Categories: Regional/Europe, Reference/Education, Society/Religion and Spirituality, Business, Business
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aolifescienceshub.com

aolifescienceshub.com aolifescienceshub.com           
Life Sciences - Allen & Overy
In our blog dedicated to Life Sciences, we report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector.


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rqteam.com

rqteam.com rqteam.com           
RQM+ | The world's leading MedTech service provider
RQM+ is the world's leading MedTech service provider, offering consulting, clinical trial, lab and reimbursement services to support the entire product lifecycle.


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thema-med.com

thema-med.com thema-med.com           
Thema - Medical Regulatory Consultancy - Quality and Regulatory Affairs for Medical Devices
Servizi di consulenza strategico-regolatoria per aziende che operano nel settore dei Dispositivi Medici, dei Dispositivi Medico-Diagnostici in Vitro...


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nbog.eu

nbog.eu nbog.eu           
NBOG - Start
ZLG, Bonn



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criticalcatalyst.com

criticalcatalyst.com criticalcatalyst.com           
CRITICAL CATALYST – Health Consulting
CRITICAL CATALYST - Health Consulting


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quasar-med.com

quasar-med.com quasar-med.com           
Quasar | High-Quality Medical Devices Manufacturing Company
Quasar delivers top-tier development and manufacturing for minimally invasive devices, catheters, and sensors, empowering life-changing therapies globally.


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qtec-group.com

qtec-group.com qtec-group.com           
Partner der Healthcare Industrie - qtec group
Partner der Healthcare Industrie, Spezialist für Regulatory and Clinical Affairs, klinische Bewertungen und Risikomanagement.


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medtecheurope.org

medtecheurope.org medtecheurope.org           
MedTech Europe, from diagnosis to cure - Homepage
The European trade association representing the medical technology industries, including medical devices, in vitro diagnostics and digital health.


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medidee.com

medidee.com medidee.com           
Medidee Services - RA, CA/CRO and QA, for MedTech
Medidee: consulting in regulatory affairs, quality insurance, clinical affairs and digital health for medical devices and in vitro diagnostics.


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bioregservices.com

bioregservices.com bioregservices.com           
BIOREG Services - Regulatory Affairs for Startup Companies
BIOREG Services - regulatory affairs for medical device and medical products startup companies. We strive to develop your idea into an approved product.



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team-nb.org

team-nb.org team-nb.org           
Bienvenue sur la page d'accueil
Team-nb.org



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meddev.info

meddev.info meddev.info           




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camd-europe.eu

camd-europe.eu camd-europe.eu           
CAMD - Competent Authorities for Medical Devices
Working Groups. Working Groups are important partners in delivering CAMD's aims and objectives. We work with a number of groups that help us in a variety of ways



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planetinnovation.com

planetinnovation.com planetinnovation.com           
Planet Innovation - Product Development & Manufacturing
A healthtech innovation and commercialization company that exists to create breakthrough products and commercially successful businesses.


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biosliceblog.com

biosliceblog.com biosliceblog.com           
BioSlice Blog
Updates & commentary on legal & regulatory developments to the European life sciences community, encompassing pharmaceuticals, biotech, medical devices, cosmetics, & foods.


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emergogroup.com

emergogroup.com emergogroup.com           
Emergo by UL - We Specialize in Global Medical Device and IVD Compliance and Innovation
Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success.


Moz DA: 49 Moz Rank: 4.1 Semrush Rank: 11,955,019 Facebook ♡: 50
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kobridgeconsulting.com

kobridgeconsulting.com kobridgeconsulting.com           
Medical Device Consulting - Regulatory & Quality | Kobridge
Medical Device consulting services - regulatory and quality - FDA, CE marking, ISO 13485, MDSAP, biological and clinical evaluation.


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med-technews.com

med-technews.com med-technews.com           
Med-Tech Innovation News | Home - Med-Tech Innovation
Latest news, insights, opinion and analysis on the Medtech industry from Medtech Innovation News - covering medical devices, medical manufacturing , covid-19, regulations, diagnostics, digital in healthcare, AI , VR and more


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1med.ch

1med.ch 1med.ch           
Contract Research Organization for Regulatory and Quality Affairs | 1Med
1Med is a contract research organization which provides services in regulatory affairs consulting, medical device quality assurance and others.


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qtspackage.com

qtspackage.com qtspackage.com           
Home - QTS
Home - QTS


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perfectusbiomed.com

perfectusbiomed.com perfectusbiomed.com           
Perfectus Biomed: Microbiology Testing and Research Services
Perfectus Biomed are leaders in standard & customized microbiology testing services for a variety of sectors, including wound care, medical devices & biocides


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fangconsulting.com

fangconsulting.com fangconsulting.com           
Medical Device Consulting | Regulatory Affairs Consulting
Fang Consulting is a staff augmentation consulting firm that offers comprehensive services for all regulatory and quality medical device needs.


Semrush Rank: 2,371,220 Facebook ♡: 461
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emergobyul.com

emergobyul.com emergobyul.com           
Emergo by UL - We Specialize in Global Medical Device and IVD Compliance and Innovation
Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success.


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mdc-ce.de

mdc-ce.de mdc-ce.de           
mdc medical device certification GmbH - Startseite
mdc medical device certification GmbH - Startseite


Moz DA: 30 Moz Rank: 2.6 Semrush Rank: 2,109,004 Facebook ♡: 0
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lne-gmed.com

lne-gmed.com lne-gmed.com           
GMED - Dedicated to Health and Innovation in Medical Devices
Learn more on GMED and how they serve the medical device industry worldwide to meet the requirements of European medical device regulations


Moz DA: 32 Moz Rank: 3.7 Semrush Rank: 500,112
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gs1belu.org

gs1belu.org gs1belu.org           
GS1 Belgium & Luxembourg
Als onafhankelijke neutrale not-for-profit organisatie brengt GS1 organisaties zoals supermarkten en drogisterijen, bouwmarkten, ziekenhuizen, hun leveranciers en logistieke dienstverleners bij elkaar. Door bedrijven globale standaarden te bieden voor de identificatie zet GS1 zich in voor een efficiëntere keten.



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lne-america.com

lne-america.com lne-america.com           
GMED - Dedicated to Health and Innovation in Medical Devices
Learn more on GMED and how they serve the medical device industry worldwide to meet the requirements of European medical device regulations


Moz DA: 20 Moz Rank: 3.2 Facebook ♡: 0
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europe-it-consulting.ch

europe-it-consulting.ch europe-it-consulting.ch           
Europe IT Consulting - ◻ ◻ ◻ Development & Consulting
◻ ◻ ◻ Development & Consulting


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ombuenterprises.com

ombuenterprises.com ombuenterprises.com           
OMBU | The Operational Excellence Company
OMBU Enterprises, LLC, The Operational Excellence Company


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enzyme.com

enzyme.com enzyme.com           
Enzyme: The only QMS software as innovative as you
Enzyme QMS software covers the key components of cGMP, the QSR, and ISO standards, and all stages of the product development lifecycle.
Chemical numbering scheme. The Enzyme Commission number (EC number) is a numerical classification scheme for enzymes, based on the chemical reactions they catalyze. As a system of enzyme nomenclature, every EC number is associated with a recommended name for the corresponding enzyme-catalyzed reaction. EC numbers do not specify enzymes but enzyme-catalyzed reactions. If different enzymes (for instance from different organisms) catalyze the same reaction, then they receive the same EC number. Furthermore, through convergent evolution, completely different protein folds can catalyze an identical reaction (these are sometimes called non-homologous isofunctional enzymes) and therefore would be assigned the same EC number.

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regdesk.co

regdesk.co regdesk.co           
Regulatory Compliance Software For Medical Devices | RegDesk
RegDesk offers an AI-powered medical devices and pharmaceutical regulatory compliance software to keep track of medical regulations. Click here to learn more!



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innovit.com

innovit.com innovit.com           
Unique Device Identification I Master Data & PIM Solutions I Innovit
Innovit is a global solution provider specializing in MDM, PIM, GDSN, UDI Compliance (Unique Device Identification) and NPI Workflow Automation software.


Moz DA: 29 Moz Rank: 3.2 Semrush Rank: 4,045,942
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thefdagroup.com

thefdagroup.com thefdagroup.com           
The FDA Group — Life Science Consulting, Staffing, and Recruitment
The FDA Group is a global leader in life science consulting, staff augmentation, recruitment, remediation, auditing, and other quality system services.


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mdrg.org

mdrg.org mdrg.org           
Home - MDRG
The Medical Device Resource Group is a coalition of independent Twin Cities companies that collectively offer the broad expertise you need to get new medical devices to market – and support them once they’ve launched. Our coalition of companies offers a broad range of expertise, useful both in developing medical devices and ensuring success once […]


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brandwoodckc.com

brandwoodckc.com brandwoodckc.com           
Leading provider of specialized services for pharma in Australia
We are the leading provider of specialized services for the pharmaceutical, biotech and medical device industries in Australia.


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unitronregulatory.nl

unitronregulatory.nl unitronregulatory.nl           
MDR and Life Science Consulting | Unitron Regulatory
Unitron Regulatory, expert in medical device regulation, life science consulting and product certification in the field of medical devices.


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leanentries.com

leanentries.com leanentries.com           
Entries - Digital Information Runways
Entries is your digital runway into medical device regulations! We help companies create viable health tech products and save time to market.


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avanti-europe.ch

avanti-europe.ch avanti-europe.ch           
Avanti Europe AG - medical device consultants and lifescience experts
Avanti Europe is a specialist consultancy and expert knowledge provider for the life science industry. We support your projects.


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ecmmedicaldevices.com

ecmmedicaldevices.com ecmmedicaldevices.com           
Fast efficient CE Marking for Medical Devices
ECM, Notified Body #1282 and ISO 13485 Certification Body supports faster European market access for medical devices


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evnia.dk

evnia.dk evnia.dk           
Evnia - To Strive, To Seek, To Find
To Strive, To Seek, To Find


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eudamed.eu

eudamed.eu eudamed.eu           
Everything EUDAMED, templates, training, software, consultancy, support
MDR EUDAMED services, EUDAMED software for data preparation, validation, and submission, training, and MDR & IVDR EUDAMED device templates


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ddismart.com

ddismart.com ddismart.com           
Clinical, Regulatory & Automation solutions for Life Sciences | DDi
Clinical, Regulatory & Automation solutions for Life Sciences | DDi


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lrqa.co.uk

lrqa.co.uk lrqa.co.uk           
LRQA UK - Assurance, Certification, Inspection, Training
We're assurance, certification and inspection service specialists. We help businesses evolve by connecting them with tomorrow’s thinking, today.


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greenlight.guru

greenlight.guru greenlight.guru           
Greenlight Guru: #1 QMS for Medical Devices | EDC for Medical Devices
Greenlight Guru brings modern QMS and EDC software to 1,000+ medical device companies helping improve speed and efficiency while reducing risk.


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dare.eu

dare.eu dare.eu           
The Official Kiwa Dare Services Homepage - DARE!! EU
Kiwa Dare Services Testing, Certification and Calibrations



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qualio.com

qualio.com qualio.com           
#1 Cloud-based Quality Management Software for MedDevice & Pharma
Be audit-ready in every way with the best QMS software for FDA, ISO and GxP Compliance. Doc Control, Training, CAPAs, NCRs, Audits, Complaints...


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atrify.com

atrify.com atrify.com           
GDSN mit atrify: Software & Services für exzellenten Product Content
Das Komplettpaket für den weltweiten & reibungslosen Austausch von Produktinformationen > FMCG, Healthcare, Foodservices, Travel Retail, DIY


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asphalion.com

asphalion.com asphalion.com           
Asphalion: Regulatory Affairs and Life Science Consulting
Asphalion is an International Scientific and Regulatory Affairs consultancy that provides assistance in Pharmacovigilance, Submissions, RIM, CMC and more.



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