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The Value of Experienced Regulatory Project Managers in the Life Sciences Industry

  • The-Value-of-Experienced-Regulatory-Project-Managers-in-the-Life-Sciences-Industry
    Industry Insights

    The Value of Experienced Regulatory Project Managers in the Life Sciences Industry

    In the dynamic and highly regulated life sciences industry, where innovation meets stringent...

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  • Industry Insights

    How CAPA and DMAIC Drive Effective QMS Implementation and Quality Remediation

    Consumers trust that medicines and medical devices are safe, effective, and high quality. We often...

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  • Regulatory Affairs CMC FDA Workshop
    Industry Insights

    Modernizing Regulatory Quality Assessments: What It Means for You and Why You Should Attend the FDA’s Workshop

    The world of Regulatory Affairs (RA) is evolving rapidly, with initiatives aimed at modernizing the...

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  • Industry Insights

    Generative AI Usage in the Medical Devices Industry

    Integrating artificial intelligence (AI) in medical devices is a rapidly evolving field. Ongoing...

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  • Industry Insights

    EU MDR Extended Transitional Period

    On March 15, 2023, regulation (EU) 2023/607 amended the Medical Device Regulation (MDR) and the In...

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  • Industry Insights

    The (not so) Soft Side of Project Management

    I’ve never liked the term “soft skills.” The ability of a leader to successfully...

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  • Industry Insights

    Emerging Trends and Tools in Program/Project Management

    Notable trends and tools shaping program/project management in 2024 The program/project management...

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  • Industry Insights

    Good Documentation Practices: A Quick Guide To Tips, Tricks, and Common Pitfalls

    The use of Good Documentation Practices (GDP) is a critical requirement for successful...

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  • Industry Insights

    Final Rule Amends Mammography Regulations to Improve Quality Care of Women

    Breast Cancer is the second leading cause of cancer-related deaths in women. The average risk of a...

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  • Industry Insights

    Problematic Predicate Devices of 510(k)s Leading to New Device Recalls

    The FDA’s 510(k) provides companies with a faster and more cost-effective clearance pathway for...

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  • Industry Insights

    Overcoming Downstream Home-Use Equipment Recalls- Part 2

    In part one, we explored the transformative impact of wearable technology. Healthcare workers can...

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  • Industry Insights

    Wearable Trend Impact in the Medical Device Industry- Part 1

    In a five-part series, let’s take a deep dive into how wearable technology has transformed the...

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