Featured Product In Regulatory Affairs
FDA Oversight of Laboratory-Developed Tests — The Impact of the Final Rule
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Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket approval. Read More
Regulatory Affairs
The MDSAP Audit Process: Latest Developments and Best Practices – Webinar Recording/Transcript
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Consumer Diagnostics and Wellness Testing: Navigating the Medical Device Regulations – Webinar Recording/Transcript
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Medical Device Cybersecurity: Understand the Latest Developments – Webinar Recording/Transcript
$287.00
CDRH’s Proposed Rule Harmonizing QSR and ISO 13485: Everything Devicemakers Must Know and Do to Prepare – Webinar Recording/Transcript
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Medical Device Regulatory Policy: Breakthrough Technologies, STeP and — Wait for It — Reimbursement – Webinar Recording/Transcript
$287.00
Spreadsheet Validation: Best Practices to Maintain Compliance – Webinar Recording/Transcript
$287.00
On-Site Inspections: They’re Back — But When, Where and How – Webinar Recording/Transcript
$287.00
The Biden Administration’s FDA: The First Six Months and What to Expect for the Rest of the Year – Webinar Recording/Transcript
$337.00
Demystifying AI in the Life Sciences Industry: What Regulatory, Quality and Compliance Professionals Need to Know – Webinar Recording/Transcript
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Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives – Webinar Recording/Transcript
$287.00