Regulatory Affairs & Intelligence
Regulatory submissions, gap and impact analysis, regulatory document review and keeping up with regulatory change.
18 articles
- Medical Device Regulatory Affairs in 2026: Role, Responsibilities and Trends What medical device regulatory affairs teams do, the skills they need, and the 2026 trends reshaping the role: eSTAR, FDA's AI tools, MDUFA VI and EUDAMED.
- Medical Device Regulatory Software: RIM, Submissions and Regulatory Intelligence Tools RIM, submission, regulatory intelligence and AI assessment tools for medical device RA teams: what they do, what changed in 2026 and how to choose.
- Regulatory Affairs in Life Sciences: What the Function Does and How It Is Changing What regulatory affairs does in pharma and medical devices, its core lifecycle responsibilities, and how eCTD 4.0, eSTAR, EU reform and AI are changing it.
- Regulatory Compliance Management for Life Sciences: Building a System That Holds Up How life sciences companies manage regulatory compliance as a system: obligations registers, controls, monitoring, inspection readiness and evidence.
- Regulatory Change Management: How to Monitor and Act on Regulatory Changes How to monitor regulatory changes and act on them: sources, triage, impact assessment and tracking, with 2025-2026 examples from FDA, EMA and the EU.
- Regulatory Intelligence: Sources, Process, Software and the Role of AI What regulatory intelligence is, the three parts of a mature RI function, what to look for in RI software, and where AI helps and where it does not.
- RIM Software: Regulatory Information and Document Management Explained What regulatory information management (RIM) software does, how it differs from document management, why IDMP and eCTD 4.0 matter, and how to choose.
- Regulatory Submission Management and Automation: eCTD, Tools and What to Automate How regulatory submissions are planned, assembled and published: eCTD 4.0 and eSTAR timelines, submission software, what to automate and AI review.
- Regulatory Gap Analysis and Impact Assessment: A Practical Method for Life Sciences How to run a regulatory gap analysis in life sciences, with QMSR, EU reform and Annex 11 examples, how it differs from a government RIA, and a template.
- Medical Device Regulations Explained: FDA Classes, Pathways and 2026 Updates How US medical device regulations work in 2026: device classes, 510(k), De Novo and PMA, the key 21 CFR parts, FY2027 fees and EU MDR updates.
- Medical Device AI in 2026: FDA Rules, the EU AI Act and What Comes Next FDA's AI device list, PCCPs, draft lifecycle guidance, LLM tagging and the EU AI Act's 2028 deadline: what medical device AI makers need to know now.
- EU MDR in 2026: Deadlines, the Simplification Proposal and a Compliance Roadmap EU MDR status in 2026: transition deadlines, mandatory EUDAMED, the Commission's simplification proposal and a compliance roadmap for US device makers.
- Regulatory Compliance AI and Automation: What Works, What Regulators Expect and How to Start How AI and automation are used in regulatory compliance in 2026, what FDA and EU regulators now expect, the risks to manage and a practical framework to start.
- CE Marking for Medical Devices: A Step-by-Step Guide for US Manufacturers (2026) How US manufacturers CE mark medical devices under the EU MDR in 2026: classification, conformity routes, notified bodies, technical documentation and EUDAMED.
- Medical Device Regulatory Assessment: How to Determine Classification, Pathway and Readiness for the US and EU How to run a medical device regulatory assessment: FDA classification and 510(k), De Novo or PMA, EU MDR class and conformity route, and readiness for 2026 rules.
- Adverse Event Reporting in the US: FDA Requirements for Drugs and Devices in 2026 FDA adverse event reporting explained: device MDR 30-day and 5-day reports, drug 15-day Alert reports, MedWatch forms, eMDR and the new AEMS system.
- Medical Device Technical Documentation Review: How to Review a Technical File Before FDA or a Notified Body Does How to review medical device technical documentation before an FDA eSTAR or notified body review: what reviewers check, common gaps and a checklist.
- Pharmaceutical Regulatory Compliance in 2026: Obligations, Enforcement Trends and Compliance Software US pharma compliance obligations in 2026, from GMP and safety reporting to advertising and Open Payments, enforcement trends and compliance software.
Subjects covered
- regulatory affairs
- regulatory affairs software
- regulatory intelligence
- regulatory intelligence software
- regulatory information management
- RIM software
- regulatory compliance management
- regulatory submission management
- regulatory submission software
- regulatory document management
- regulatory assessment
- regulatory gap analysis