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Topics

Topics

A few of the topics we work on and write about most, not the full list of what we support. Each page covers how we help, recent writing and source documents from our library.

AI/ML software as a medical device

Intended use and pathway

Pre-Submissions

Validation and submission

PCCPs and lifecycle

FDA submissions and pathways

Classification and pathway

Pre-Submissions

510k and De Novo

Breakthrough and PCCPs

Medical device cybersecurity

Threat modeling

SBOM and vulnerabilities

Security risk management

Testing and postmarket

Quality systems for SaMD, medical devices and digital health

QMS setup and audits

Software lifecycle and risk

V&V planning and testing

QMS tool validation

EU, UK and international markets

MDR technical documentation

Global strategy

Human factors and usability

Use-related risk analysis

Formative evaluations

Validation testing

Submission content

Something else?

Don't see your topic?

We support regulatory, quality and product development work well beyond this list. Tell us what you're working on.

More from Cosm

Regulatory documents with short summaries, filterable by topic.

Plain-language notes on new guidance and standards.

Templates for teams that want to build their quality system themselves.

Planning a submission, a quality system or a new product? Talk it through with Cosm.