510k Guidance

510(k) Guidance

Global approvals are easier for medical device firms when they automate 510(K) submission tasks.

The Food and Drug Administration's (FDA) 510(k) Guidance document outlines the steps medical device companies follow to bring a product to market. MasterControl will increase your chances for success. Ensure all materials and tasks for every market are complete, compliant and on time.

MasterControl Registrations™

Streamline global compliance.


Automated Processes and Consistent Submissions


Equip your staff with the right tools for 510(k) content management, change control, CAPA, documents, etc. on a single platform.


Efficient Dossier Management


MasterControl provides 510(k) help by keeping all regulatory requirements in order and up to date. The global marketplace is vast, but the right solution makes compliance easier.


Audit-Ready 510(k) Submissions


Comply with the 510(k) medical device design guidelines. Quickly access data to easily compile and create complete records of all design and development phases.

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Efficient Management of 510(k) Submission Materials

Losing a design history file (DHF) or any other FDA 510(k) content results in costly setbacks. Keep all documents in order, reduce risks and never omit any important submission items, tasks or deadlines.


Proactively Prepare for Audits

510(k) submissions go much smoother when you have immediate access to all your data history, documents and artifacts. It’s also valuable to have a complete view of change control, CAPA, training, etc. processes and records.

A Smooth Pathway to 510(k) Approval

Gain a competitive edge by streamlining 510(k) submissions and market launches.

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