Medical Devices
Creating a device that is approved by the FDA.
Relevant Topics:
General Wellness
Class I/II/III Medical
510(k) Submission
PMA Submission
Manufacturing
Product Design
Product Design
Medical devices have a much higher standard for manufacturing quality.
Have your product designed for comfort, user safety, and reliability.
Get connected with an ISO certified manufacturer for mass production.
Get assistance with product certification and compliance with FDA regulation.
Take advantage of ancillary services such as photo-realistic renderings.
For more information, see the services page.
Classification
Determined by research and 513(g) request.
Non-Medical or General Wellness devices are not subject to FDA controls.
Medical Devices are subject to FDA Controls and Marketing Authorization.
Marketing claims can unintentionally put a device into the medical category.
Receive guidance about product design and marketing claims.
FDA Controls
Every medical device (Class I/II/III) is subject to General Controls, QMSR, and ISO-13485.
Not all manufacturers are ISO-13485 certified or FDA registered.
Get connected with the right manufacturer and have an expert facilitate.
Class II devices also have Special Controls.
The OEM and the manufacturer must have their own implementations of QMSR.
We do not offer General Controls or QMSR implementation as a service.
For more information, see manufacturing services.
Marketing Authorization
Some Class I/II devices require 510(k).
Get help identifying a predicate device and build a case for substantial equivalence.
Devices without a valid predicate must go through the De Novo process.
All Class III devices require PMA.
Get assistance with device descriptions and performance data for FDA submissions.
Optimize the regulatory pathway of your product through design choices.
For more information, see certification services.