IntelaSolve™ Insights
Practical guidance on life sciences compliance.
Clear, expert guidance on compliance infrastructure, regulatory strategy, clinical operations, and post-market surveillance — written for the teams responsible for compliance every day.
6 articles
Regulatory Submissions
·8 min read
eSTAR Is Now the Submission Standard: What 510(k) and De Novo Teams Should Fix Before They File
FDA’s eSTAR process is now central to 510(k) and De Novo submissions. Learn how medical device manufacturers can prepare structured evidence, reduce rework, and strengthen submission readiness.
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Supplier Quality
·8 min read
FDA’s Data Integrity Warning for Device Submissions: What Manufacturers Should Learn About Third-Party Testing
FDA’s 2026 medical device data integrity notification highlights the risk of unreliable third-party testing data. Learn how manufacturers can strengthen supplier qualification, evidence review, and submission readiness.
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Regulatory Operations
·8 min read
EUDAMED Is Mandatory: Why Device Data Governance Now Belongs in Your Quality System
EUDAMED’s first four modules are now mandatory. Learn why medical device and IVD manufacturers need stronger device data governance, UDI control, certificate alignment, and lifecycle ownership.
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Quality Systems
·8 min read
QMSR Is No Longer a Future Deadline: What FDA Inspection Readiness Looks Like Now
FDA’s QMSR is now in effect. Learn what medical device manufacturers should do to prepare quality systems, records, supplier controls, and management review for the new inspection environment.
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Quality Management
·7 min read
Quality Assurance vs Quality Control: What's the Difference?
QA and QC are often used interchangeably, but they describe two distinct disciplines in a life sciences quality management system. Here's how they differ — and how they work together under FDA and ISO 13485.
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Compliance
·9 min read
The CAPA Process Explained: A Step-by-Step Guide for Life Sciences Teams
Corrective and Preventive Action (CAPA) is one of the most cited subsystems in FDA Form 483s. This guide walks through the eight stages of a defensible CAPA process under 21 CFR 820.100 and ISO 13485.
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