Clinical Login Support Contact Sales
Products

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

Learn More

Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

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

View Product Tour

Accelerate development with integrated design control and risk software.

Learn More

Featured Capabilities:

Design Controls Risk Management Risk Intelligence

Schedule a custom demo of Greenlight Guru Product now.

REQUEST A DEMO

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

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

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
Pricing
Request a Demo
Request a Demo

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.

Watch the webinar
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

richard_young_round
Presenter: Richard Young

Founder & Managing Director, Acclaim Biomedical Consulting Ltd
jon-speer-80px-circle-1
Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

acclaim_biomedical_logo

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.

greenlight-guru-logo

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.

Featured In