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.
23 articles
Regulatory Strategy
·7 min read
A New Sunscreen Active Does Not Make Every Formula Market-Ready
FDA added bemotrizinol to the OTC sunscreen monograph effective August 9, 2026. Learn how to assess eligibility and exclusivity, translate monograph conditions into design inputs, and build the reformulation evidence package.
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Quality Systems
·7 min read
Ebola Readiness Begins Before FDA Activates the Questions
FDA's updated Ebola guidance for blood establishments separates always-on preparedness from outbreak-triggered controls. Learn how to build activation control, deferral logic, product traceability, and deviation reporting.
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Regulatory Strategy
·7 min read
CMC Flexibility Still Needs an Evidence Plan
FDA's CMC flexibilities guidance for cell and gene therapy is not a lower quality standard. Learn how to document lifecycle decisions, comparability and platform knowledge, PPQ rationale, and post-approval commitments.
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Regulatory Strategy
·6 min read
UDI Ownership Stops at the Manufacturer
MDCG 2026-5 confirms that UDI-DI assignment stays with the legal manufacturer even for distributor-branded devices. Learn how to audit issuing-entity ownership, reconcile EUDAMED data, and fix contracts and change control.
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Regulatory Strategy
·7 min read
Human Factors Evidence Now Needs a Submission Category
FDA's final human factors guidance uses three submission categories to set evidence depth. Learn how to build the URRA backbone, document the category decision, and prepare Category 1, 2, and 3 content.
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Supplier Quality
·7 min read
A Combination-Product Supplier Change Is Not Closed Until the Evidence Connects
Combination-product supplier changes touch device, drug, and quality frameworks at once. Learn how to assess materials, process and test-method changes, notification routing, and closure criteria so the evidence chain stays intact.
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Labeling
·6 min read
Electronic Instructions Need the Same Discipline as the Device
Electronic instructions for use are a controlled labeling output. Learn how to govern eIFU version linkage, availability and fallback, language and accessibility, paper-copy requests, and archival retrieval.
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Quality Systems
·6 min read
Cosmetic Adverse-Event Records Are Becoming Inspection Evidence
MoCRA makes cosmetic adverse-event reporting and recordkeeping an evidence discipline. Learn how to design intake, seriousness screening, product traceability, signal review, and retrievable case files.
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Cybersecurity
·8 min read
Cybersecurity Evidence Has to Survive the Next Release
Connected-device cybersecurity evidence decays when ownership is fragmented. Learn how to maintain a living evidence set covering baselines, vulnerability decisions, update and disclosure records, and retrieval testing.
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Regulatory Operations
·8 min read
A PCCP Is a Release Discipline, Not a Filing Artifact
A predetermined change control plan only works when it becomes an operating process. Learn how to translate a PCCP into release controls, boundary assessments, evidence gates, change packets, and configuration discipline.
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Regulatory Operations
·8 min read
Device Registration Data Is Now a Quality System Asset: How Global Manufacturers Should Take Control
Device registration, UDI, certificate, market access, and product master data obligations are becoming quality system responsibilities. Learn how global medical device manufacturers should control registration data.
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Supplier Quality
·8 min read
Supplier Monitoring Under QMSR: Why Qualification Files Are No Longer Enough
QMSR and ISO 13485 make supplier monitoring a continuing quality system obligation. Learn why medical device manufacturers need risk-based supplier oversight, performance evidence, CAPA links, and change control.
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Post-Market Surveillance
·8 min read
FDA Early Alerts Are a Recall Readiness Test: Can Your Quality System Move Fast Enough?
FDA early alerts and recall activity show why medical device manufacturers need connected complaint handling, risk decisions, product scope data, field action workflows, CAPA, and customer communication evidence.
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Diagnostics
·8 min read
IVDR Clinical Evidence Is Becoming a Living System: What Diagnostics Manufacturers Should Do Next
IVDR and global IVD evidence expectations are pushing diagnostics manufacturers toward living clinical evidence systems. Learn how to connect scientific validity, analytical performance, clinical performance, PMS, and change control.
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AI Compliance
·8 min read
EU AI Act Transparency Is Days Away: What AI-Enabled Device Manufacturers Should Fix Now
EU AI Act transparency obligations begin August 2, 2026. Learn how AI-enabled medical device and IVD manufacturers should connect transparency, risk, QMS, technical documentation, and post-market monitoring.
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Post-Market Surveillance
·8 min read
Great Britain’s PMS Requirements Are in Force: What Manufacturers Should Do Now
Great Britain’s strengthened post-market surveillance requirements are now in force. Learn how medical device and IVD manufacturers should connect PMS plans, complaints, vigilance, trend analysis, and reports.
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Quality Systems
·8 min read
Computer Software Assurance Is Here: Why Medical Device Manufacturers Should Rethink QMS Software Validation
FDA’s Computer Software Assurance guidance supports a risk-based approach to production and quality system software. Learn what medical device manufacturers should update in their eQMS, ERP, MES, LIMS, and validation programs.
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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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