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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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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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

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FREE ON-DEMAND WEBINAR

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

Join clinical trial expert Alethea Wieland as she presents her most valuable tips and tricks to help clinical, regulatory, quality, and marketing teams develop a clinical trial program that fulfills global compliance requirements, meets the needs of patients in various regions around the world, and serves as an ongoing compendium of evidence generation.

This free, in-depth webinar will use similar-type case studies that will show you what to expect and do for a successful clinical trials program and market launch for Non-significant Risk (NSR) devices, IVDs, Software as a Medical Device (SaMD), De Novos, traditional Class II and III devices, Digital Therapeutics, and Wellness devices.

Learn about customizable, creative approaches you can use to develop a robust clinical trial program that meets the needs of all relevant stakeholders, taking into account the stringent realities of regulations, like the European Medical Device Regulations (EU MDR), in an attempt to strike the right balance.

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Specifically, this webinar will cover:
  • Clinical, Regulatory, Quality, and Marketing Working Together From the Start
  • Establishment of Intended Use and Indications for Use
  • Early Product Development (e.g., proof-in-concept, early feasibility, or training set trials) That Attracts Early Investors
  • Pilot-to-Pivotal Clinical Trials and Publications Strategies
  • Post-Market Clinical Follow-up Studies, Investigator-Initiated Trials (IIT), Post-Approval R&D For New Indications, and Similar Surveillance Programs
Who Should Attend?
  • Clinical, Regulatory, Quality, and Marketing Teams who work together in the development and management of a clinical trials program.
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Presenter: Alethea Wieland

Founder and President, Clinical Research Strategies
Ryan-Behringer
Moderator: Ryan Behringer

Training and Onboarding Medical Device Guru, Greenlight Guru

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About Clinical Research Strategies

Clinical Research Strategies (“CRS”) is a specialty CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, attorneys, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and sales and marketing teams to take on the biggest challenges for start-up, mid-sized and large life sciences companies. For more information, please visit their website by clicking here.

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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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