Regulatory & Compliance Perspectives
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Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters
8/19/2025
This article focuses on practical strategies for medical device companies to strengthen their quality management systems and develop proactive programs that anticipate issues before they attract FDA action.
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Regulatory Planning In Early Medtech Development Is The Recipe For Success
8/18/2025
Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to obtain clearance or approval. That mindset is no longer enough.
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The U.K. Now Classifies Ambient Voice Technology As SaMD
8/14/2025
The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as software as a medical device (SaMD).
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The Warning Letter Wake-Up Call In 2025: What FDA Enforcement Is Really Telling Us
8/12/2025
FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.
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EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance
8/6/2025
The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.
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Audit Trail Compliance And What To Look For In Mitigation Software
7/9/2025
In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.
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Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance
7/7/2025
The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.
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Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials
7/3/2025
Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape.
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
6/23/2025
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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How Is RIM Software Transforming Regulatory Compliance?
6/20/2025
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.