Successful Device Submissions and Approvals – Key Elements

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More than ever before, medical devices are playing an ever increasing role in the healthcare of individuals across the world. Some medical devices pose little or no risk to patients while others can be life-sustaining.
Medical devices utilize a variety of technologies to include electronics, mechanics, pneumatics, software, and chemical and/or biological action to achieve their intended function.
Regulatory submissions for medical devices to achieve government approval to market and manufacture varies globally and is as complex a process as the devices themselves.

Why should you attend this webinar?

The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its intended use and is safe to patients, consumers, and health professionals.
Regulatory submissions that are poorly structured and organized making information retrieval difficult and that do not meet regulatory requirements, are missing essential information, and demonstrate inconsistencies, extend the time required for approval and essentially extend the ultimate time to market.
This webinar is intended for professionals to the medical device industry who require a basic foundational understanding and familiarization of the entire process as a precursor to more advanced instruction concerning the subject

Areas Covered in the Session:

US Submissions Overview
Options for bringing products to market
510 (k)
De Novo

Differences between 510(K) and PMA
510 (k) Process Steps:

Step 1 – Confirm your product is a medical device
Step 2 – Identify a Predicate Device
Step 3 – Identify applicable standards/guidance documents
Step 4 – Prepare and submit application

PMA Application Methods

Product Development Process
Humanitarian Device Exemption

Who can Benefit:

This webinar is geared toward new professionals in the medical device industry or professionals who need to gain a basic understanding of the submissions process.
Those that will benefit by title and function include: Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that require a basic understanding of the regulatory submissions process.


Compliance Key INC

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