Medical device market intelligence and global FDA pathways
Practical analysis for MedTech regulatory triage: global FDA pathways such as 510(k), De Novo and PMA, EU MDR and UKCA routes, AI-enabled devices, quality systems, and the medical device market intelligence behind deciding where to launch next.
Design history file requirements: what belongs in a medical device DHF
What a design history file must contain under 21 CFR 820.30 and ISO 13485, how the DHF relates to the DMR and DHR, and how to keep it audit-ready.
Read articleUKCA marking for medical devices: MHRA registration and the route to Great Britain
What UKCA marking requires for medical devices, how MHRA registration and UK Responsible Person duties work, and how the Great Britain route differs from EU MDR.
Read articleEU MDR classification rules: how to classify a medical device under Annex VIII
A practical walkthrough of EU MDR classification: the Annex VIII rules, Class I to III, Rule 11 for software, and what each class means for conformity assessment.
Read articleFDA premarket pathways explained: 510(k), De Novo, PMA and exempt
How to choose between 510(k), De Novo, PMA and exemption — what each FDA premarket pathway requires, how long it takes, and how to tell which one fits your device.
Read articleSoftware as a Medical Device: FDA, EU MDR and UKCA routes for SaMD teams
How SaMD is classified and regulated across the US, EU and UK — FDA pathways for software, EU MDR Rule 11, and UKCA and MHRA considerations for digital health teams.
Read article510(k) predicate search: how to find and defend a predicate device
A practical method for 510(k) predicate search: what makes a valid predicate, how to use K-numbers and product codes, and how to document substantial equivalence.
Read articleFDA device classification: how to find your device class and product code
How FDA device classification works, how to find the right product code, and what Class I, II and III mean for your premarket pathway.
Read articleDigital Health and Medical Device: What is the Difference?
FDA's digital health device lists and why the September 2026 update matters for teams drawing the line between wellness software and a regulated device.
Read on cahir.aiMedTech Industry Pulse — August 2026 Roundup
The month's regulatory signals, clearances and policy movement across the medical device landscape.
Read on cahir.aiRobotic Phlebotomy Market Readiness: What 14 Countries Have in Common After Aletta's FDA Clearance
Fourteen countries just cleared the bar for robotic phlebotomy — what their shared conditions say about where to launch next.
Read on cahir.aiMedTech Industry Pulse — July 2026 Roundup
July 2026 roundup: a SaMD and clinical decision support device focus issue.
Read on cahir.aiMedical Device Approvals and Clearances Report
Strategic trends to watch and priorities for the next quarter, drawn from recent approval and clearance data.
Read on cahir.aiMedTech Industry Pulse — June 2026 Roundup
The June 2026 regulatory and commercial roundup for medical device teams.
Read on cahir.aiCahir Solutions Launches MedCompass MVP to Help MedTech Teams Move Faster Toward Commercialization
Announcing the MedCompass MVP — market intelligence and regulatory triage built to shorten the path to commercialization.
Read on cahir.aiFrom Reactive to Proactive: Bridging the Postmarket Surveillance Design Gap in MedTech
A closed-loop quality framework for post-market surveillance that feeds real-world signals back into design.
Read on cahir.aiMedTech Industry Pulse — May 2026 Roundup
The May 2026 regulatory and market roundup for medical device teams.
Read on cahir.aiGuidance for AI-Enabled Medical Devices
Key insights and takeaways for 510(k) study design and data expectations for AI-enabled devices.
Read on cahir.aiChoosing the Right FDA Product Code
Why the product code you pick shapes your submission strategy and your development plan.
Read on cahir.aiAI/ML Trends in MedTech
Navigating the surge in AI/ML-enabled device approvals and what it means for new entrants.
Read on cahir.aiSaMD, CDS Software, and AI-Enabled Medical Devices
What innovators need to know before going to market with software as a medical device.
Read on cahir.aiMedTech Industry Pulse — April 2026 Roundup
The April 2026 regulatory and commercial roundup for medical device teams.
Read on cahir.aiMedTech Weekly Insights
FDA, CDRH and global regulatory signals shaping the market.
Read on cahir.aiA Strategic Guide to Medical Device Submissions and the Q-Sub Advantage
Choosing the right submission pathway and engaging the FDA early through the Q-Submission program.
Read on cahir.aiIntegrating Intellectual Property Strategy into Medical Device Development and Commercialization
How IP strategy should be built into device development and commercialization rather than bolted on.
Read on cahir.aiThe Human-in-the-Loop Illusion
Why checking the box on AI safety is not enough for regulated medical software.
Read on cahir.aiMedTech Industry Pulse — March 2026 Roundup
The March 2026 regulatory and market roundup for medical device teams.
Read on cahir.aiHow the FDA's Evolving AI Frameworks Are Reshaping MedTech
What the FDA's shifting AI guidance means for device developers and their evidence plans.
Read on cahir.aiISO 13485:2016 and Certification
ISO 13485:2016 defines the requirements for a quality management system — here is what certification involves.
Read on cahir.aiFDA's New Quality Management System Regulation
What medical device manufacturers need to know about the new QMS regulation.
Read on cahir.aiWhy MedTech Companies Are Rethinking How They Operate
Building outcome-oriented organizations for sustainable growth in medical technology.
Read on cahir.aiHealth Equity
Health equity and population health outcomes — and what they mean for device access.
Read on cahir.aiA 510(k) (Premarket Notification)
A 510(k) premarket notification is a regulatory dossier submitted to the FDA — here is how it works.
Read on cahir.aiAI Safety and Trust Frameworks
A ranking and strategic analysis of the leading AI safety and trust frameworks.
Read on cahir.aiRAG and LLMs
Understanding retrieval-augmented generation systems and how they enhance large language models.
Read on cahir.aiIn-depth guides
Longer references on medical device market intelligence, global FDA pathways and MedTech regulatory triage.