Launching a medical device is only the beginning of its regulatory lifecycle. Once the device reaches users, manufacturers must maintain effective post-market surveillance, evaluate complaints and identify reportable events while keeping the quality management system current and inspection-ready. This webinar explores how an effective QMS supports these responsibilities after launch.
Attendees will examine the elements of a healthy post-market system, including processes for monitoring device performance, managing complaints and determining when an event requires Medical Device Reporting. The session will also address how quality and regulatory teams can maintain documentation, identify emerging signals and respond before isolated issues develop into broader compliance risks.
The webinar will also cover practical considerations following an FDA inspection, Form 483 or Warning Letter. Attendees will learn how to assess observations, prepare timely responses and address the underlying system weaknesses that contributed to the findings.
Register for this webinar to learn how a QMS can support post-market compliance, timely reporting and continued medical device availability.
Speaker
Etienne Nichols, Head of Industry Insights & Education, Greenlight Guru
Etienne Nichols is Head of Industry Insights & Education at Greenlight Guru and the Host of the Global Medical Device Podcast, where he’s interviewed hundreds of medtech leaders about how devices get built, cleared and kept on the market. He’s a Mechanical Engineer by training with a PMP from PMI, and he came up through manufacturing. After running UDI and direct part marking across 250+ Class II neurosurgical devices at Integra LifeSciences, he managed a drug-delivery combination product at Enable Injections. At Greenlight Guru, he’s helped dozens of device companies get their design controls, risk management and quality systems right and audit-ready. Now he writes and teaches for the people doing the work, in plain English.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Quality and regulatory professionals responsible for post-market and compliance
- Medical device founders and business leaders preparing for or managing a commercial launch
- Professionals responsible for complaint handling, CAPA and post-market surveillance
- QA/RA teams preparing for an FDA inspection or Notified Body audit
- Professionals responsible for maintaining or improving an existing QMS
What You Will Learn
Attendees will gain insight into:
- Establishing post-market surveillance processes that identify device performance and safety signals
- Managing complaints and determining when an issue becomes a reportable adverse event
- Responding to Form 483 observations and Warning Letters while addressing underlying quality system deficiencies
- Maintaining an audit-ready QMS after a medical device reaches the market
Xtalks Partner
Greenlight Guru
Cloud eQMS software built for medical device companies to manage quality, design controls, and regulatory compliance from development through commercialization.
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