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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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FREE ON-DEMAND WEBINAR

How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.

The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.

Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.

The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.

Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.

Join us for this free, 90 minute webinar presented by our guest Richard Young, Managing Director at Acclaim Biomedical Consultants, where he will be sharing will you in detail what all the significant changes are and how you can begin preparing for compliance now.

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Specifically, this webinar includes:
      • Why the European regulations are changing
      • What does the new regulation mean for IVD manufactures
      • How to classify your IVD using the new risk-based classification system
      • How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
      • An overview of all the most significant changes brought by the IVDR
      • What IVD manufactures can do to start preparing now
Who Should Attend:
      • In Vitro Diagnostics Executives and CEOs
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Clinical Affairs Professionals and Management 
      • R&D Engineers and Management

Hosted by

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Presenter: Richard Young

Founder & Managing Director, Acclaim Biomedical Consulting Ltd
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Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

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About Acclaim Biomedical Consulting

Our aim at Acclaim Biomedical Consulting (ABC) is to provide you with an independent, pragmatic approach to meeting the ever changing regulations of the healthcare and biomedical industries so that you can manage your business successfully. By using our network of expert consultants, associates and partner companies we can bring together decades of relevant experience – from quality assurance and clinical research to product design and market development. Click here to learn more.

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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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