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CMS New Technology Add-on Payment (NTAP) is the fastest path to Medicare reimbursement for by providing additional Medicare payments...

The EU AI Act is a risk-based regulation requiring AI medical devices to undergo dual compliance, single integrated CE: NB assesses AIA +...

EU AI Act requires separate AI system certification alongside medical device approval, with 36-month implementation timeline. FDA's PCCP...

IMDRF is the global forum harmonizing medical device regulations across major markets (FDA, MHRA, Health Canada, EU). On Jan, 2025, IMDRF...

A Predetermined Change Control Plan (PCCP) is FDA documentation that lets you pre-define specific AI/ML software changes—and the methods...

FDA AI medical device regulation received major updates with comprehensive draft guidance for artificial intelligence-enabled devices. On January 7, 2025 , FDA issued draft guidance  for AI-enabled device software functions (DSF)  that applies a Total Product Life Cycle (TPLC)  approach. It recommends  what to include in submissions: model description, data lineage/splits, performance tied to claims, bias analysis/mitigation, human-AI workflow, monitoring, and—if you’ll updat

FDA's new cybersecurity compliance standards carry criminal penalties and RTA threats that can destroy medical device companies. With the...

A Software Bill of Materials (SBOM)  is a machine-readable inventory  of every software component in your device—proprietary, OTS, and...

Most SaMD 510(k)s  hit a first-cycle Additional Information (AI) letter , not a final rejection. The recurring issues: missing...

SaMD (Software as a Medical Device)  is software with a medical intended use  that works independently of device hardware . SiMD...

Sam Altman’s June 10, 2025 essay, “ The Gentle Singularity ,”  sketches a near-term AI timeline—2025 agents doing real cognitive work,...

Good Machine-Learning Practice (GMLP)  = ten regulator-endorsed principles for AI/ML medical devices, covering data, design, validation,...

To structure SaMD clinical evidence, build three pillars: valid clinical association  (link SaMD output to the condition), analytical...

In 2025, FDA reviews a risk-based  software evidence package per the Device Software Functions (DSF)  guidance: choose Basic  or Enhanced...

FDA’s Jan 7, 2025 draft  for AI-enabled device software functions  recommends including: model description, dataset lineage/partitions...

In June 2025  FDA finalized its cybersecurity guidance and clarified §524B  obligations for “ cyber devices .” For SaMD that connects to...

Integrate IEC 62304  (software lifecycle) with ISO 14971  (risk management) by mapping hazards → requirements → design → tests →...

Use an FDA Pre-Submission (Q-Sub)  when your SaMD has novel tech/claims , unclear classification/pathway , clinical evidence  questions,...

Starting October 1, 2025 , all De Novo requests for SaMD  must be submitted using the FDA’s eSTAR template . This shift brings new module...

Choosing a SaMD pathway depends on risk, novelty, and predicates . Use 510(k)  when a suitable predicate exists for the same intended use...