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Medical device consulting services Medical Device Academy

Are you a start-up device company that needs medical device consulting services and training for an FDA 510k submission?

Categories: Business, Business
Topics: 510k database, design history file example, meddev 2.7.1, medical device 510k submissions, post market surveillance plan template, post-market surveillance plans, quality systems and training medical device academy

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greenlight.guru

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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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emergobyul.com

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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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emergogroup.com

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Emergo by UL - We Specialize in Global Medical Device and IVD Compliance and Innovation
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orielstat.com

orielstat.com orielstat.com           
Oriel STAT A MATRIX | Medical Device Training, Consulting & Audits
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lne-america.com

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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


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namsa.com

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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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imdrf.org

imdrf.org imdrf.org           
International Medical Device Regulators Forum (IMDRF) | International Medical Device Regulators Forum
The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory harmonization and convergence.


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ce-marking.com

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fmdic.org

fmdic.org fmdic.org           
FDA Medical Device Industry Coalition (FMDIC)
The FDA Medical Device Industry Coalition (FMDIC), composed of members of the Dallas District FDA Staff and individuals from associations representing the medical device industry, was formed to promote communication, education and cooperation between the regulators and the regulated industry.


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medtechintelligence.com

medtechintelligence.com medtechintelligence.com           
Home - MedTech Intelligence
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mastercontrol.com

mastercontrol.com mastercontrol.com           
Quality Management Systems and Solutions | MasterControl
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medicaldevicesgroup.net

medicaldevicesgroup.net medicaldevicesgroup.net           
Medical Device Industry Resources & Healthcare Technology Discussion
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rqteam.com rqteam.com           
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starfishmedical.com

starfishmedical.com starfishmedical.com           
StarFish Medical
Award-winning medical device development, design and flexible 13485 manufacturing outsourcing services. Box build, complex low-mid volume production.



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elsmar.com elsmar.com           
The Elsmar Cove Quality Forum - Helping Industry Professionals Succeed in Improving Quality and Exceeding Standards
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meddeviceonline.com

meddeviceonline.com meddeviceonline.com           
Med Device Online: Advancing human health by connecting people, organizations, and ideas in the design and development of medical devices.
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i3cglobal.com

i3cglobal.com i3cglobal.com           
World-Class Medical Device Regulatory Consulting Services
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MassMEDIC - The Heart of HealthTech
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ombuenterprises.com ombuenterprises.com           
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johner-institute.com

johner-institute.com johner-institute.com           
Johner Institute - your regulatory partner
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CE Marking: Your Definitive Guide - cemarking.net
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mddionline.com mddionline.com           
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qualio.com

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#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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thefdagroup.com

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Just a moment...


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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.


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13485store.com

13485store.com 13485store.com           
The ISO 13485 Store - Instructions, Materials & Services for Certification
The ISO 13485 Store provides instructions, materials, and services for your organization to become certified in the ISO 13485 Quality Standard.



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complianceonline.com

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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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601help.com

601help.com 601help.com           
Medical Device Design for IEC 60601-1
601help, The Medical Device Developers Guide to IEC 60601-1



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omtecexpo.com

omtecexpo.com omtecexpo.com           
Home - OMTEC
OMTEC is the world's most comprehensive orthopedic design and manufacturing event for engineers and executives


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omnica.com

omnica.com omnica.com           
Home - Omnica Corporation
Rapid medical device development from world class specialists. We’re a premier product development firm that’s able to build almost any medical device.


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bonezonepub.com

bonezonepub.com bonezonepub.com           
Home - BONEZONE
Go-to resource for orthopedic product development engineers, global sourcing professionals and device company executives.



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presentationeze.com

presentationeze.com presentationeze.com           
PresentationEZE
PresentationEZE


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advamed.org

advamed.org advamed.org           
AdvaMed - Advanced Medical Technology Association
AdvaMed is the world’s largest medical technology association representing device, diagnostics and digital technology companies.


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registrarcorp.com

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registrarcorp.com
registrarcorp.com


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rmras.org

rmras.org rmras.org           
Rocky Mountain Regulatory Affairs Society - Home
Rocky Mountain Regulatory Affairs Society, Centennial


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rigelmedical.com

rigelmedical.com rigelmedical.com           
Biomedical Test Equipment from Rigel Medical
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rcainc.com

rcainc.com rcainc.com           
Life Science Consultants | Pharmaceutical | Medical Device | RCA®
Click to learn more about RCA's life science consultants and how we support our pharmaceutical, biotech & medical device global clients.


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obelis.net

obelis.net obelis.net           
Your trusted partner for regulatory compliance
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CROMSOURCE - CRO Europe | CRO North America | CROMSOURCE
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FDAnews — Information you need!
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praxiom.com

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ISO Standards and NIST Frameworks in Plain English
Quality, environmental, risk management, information security, cybersecurity, privacy, business continuity, food safety, occupational health and safety translated into plain English.


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Read Me. - Articles about entrepreneurship, traveling, business and life from Alvin Tai
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regdesk.co

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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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mdiconsultants.com mdiconsultants.com           
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FDA consulting for the medical device industry, pharmaceutical industry and food industry for US and EU FDA quality assurance.



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certification-experts.com certification-experts.com           
Certification Experts
Product compliance made easier


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The Clever Compliance blog - A blog about product compliance, certification, and product markings. Read here our latest posts.


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510kfda.com

510kfda.com 510kfda.com           
510K FDA Device Clearance Consulting - 510kfda
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sterlingmedicaldevices.com sterlingmedicaldevices.com           
Medical Device Software & System Development Company
The Sterling Medical Device Company brings more than 20 years of experience, innovation and precision to the medical device product design and development process.


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aami.org

aami.org aami.org           
AAMI Main Page | AAMI
The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.
International scientific society. The Association for the Advancement of Artificial Intelligence (AAAI) is an international scientific society devoted to promote research in, and responsible use of, artificial intelligence. AAAI also aims to increase public understanding of artificial intelligence (AI), improve the teaching and training of AI practitioners, and provide guidance for research planners and funders concerning the importance and potential of current AI developments and future directions.

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Under Construction - FDA eCopy Print & Ship Services
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BSI Group, UK standards body, Global certification company. Training, Kitemark, Healthcare, Supply Chain, Compliance, Consultancy, ISO 9001 14001 45001 27001. We are a global leader of standards solutions helping organizations improve.


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mdtmag.com mdtmag.com           
OpsAny|Web Firewall



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Operon strategist medical device consulting firm, provides turnkey solutions to the medical device manufacturer who wants to set up world class manufacturing unit


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fdahelp.us

fdahelp.us fdahelp.us           
How to get FDA Registration - FDA Certificate
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API or medical device in the USA.


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pathwise.com

pathwise.com pathwise.com           
PathWise- Training- Regulated Life Science Quality & Compliance
PathWise provides methodologies in quality and compliance for the regulated life science industry. PathWise uses practical, hands on solutions.


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DQS | Audits und Zertifizierung | Simply leveraging Quality.
Zuverlässige und nachhaltige Zertifizierungen und Begutachtungen - mit der Deutschen Gesellschaft zur Zertifizierung von Managementsystemen als Ihrem Partner.


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insidemedicaldevices.com

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criterionedge.com

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


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pharmdevgroup.com

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Pharmaceutical Development Group (PDG) is your pharmaceutical consultant, consulting services for U.S. FDA submission, launch and post-approval strategic product planning services. Our collective knowledge and experience spans a variety of dosage forms and therapeutic areas. Contact PDG for help with your next project.


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FDA and Regulatory Consulting to Medical Device Makers Worldwide
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emwa.org

emwa.org emwa.org           
European Medical Writers Association
This website offers access to EMWA's journal Medical Writing, as well as our Freelancer and Company listing and our Jobs page advertising vacancies for both freelance and in-house medical writers and editors.


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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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cfpie.com

cfpie.com cfpie.com           
Pharmaceutical, biotech, medical device training courses | CfPIE
CfPIE provides pharmaceutical training courses and certifications in compliance and regulation for the biotech, medical device, and skin/cosmetics industries.


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freyrsolutions.com

freyrsolutions.com freyrsolutions.com           
Global Regulatory Solutions and Services Company
Freyr is a Global Regulatory Solutions and Services company, focusing on the entire Regulatory value-chain ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions to post approval maintenance, Labeling, Artwork Change Management for Pharmaceutical, Generics, Medical Device, biotechnology, Biosimilar, Consumer Healthcare, Cosmetic companies across the globe.


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aligned.ch

aligned.ch aligned.ch           
Aligned Elements - the Medical Device Application Lifecycle Management (ALM) software for Design History File management
Aligned Elements is a leading Medical Device Design Control Software for Design History File and Technical File management.


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globalregulatorypartners.com

globalregulatorypartners.com globalregulatorypartners.com           
Homepage - Global Regulatory Partners, Inc.
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raps.org

raps.org raps.org           
Regulatory Affairs Professionals Society | RAPS
RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.


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