2017 Annual Event Ticket Giveaway

by | Apr 5, 2017 | Uncategorized

EMMA International Consulting Group, Inc., is proud to be a Silver Sponsor of The Manufacturer’s Association of Central Pennsylvania’s 2017 Annual Event.  This year we will be offering one (1) complimentary ticket to the Annual Event to the first eight (8) individuals to call in to EMMA International at 248-987-4497. (Limit one ticket per company.)

WAIT THERE’S MORE……

In addition to this giveaway, EMMA International is offering two (2) complimentary tickets for companies who take advantage of our special limited time only Association member discount price for our Quality Review (valued at $125!) and Regulatory Review (valued at $200!) services, each marked-down to $100 for companies who register for either service.  You can read more about our Quality and Regulatory Services here.

Call 248-987-4497 or click here for more information.

To learn more about the great work of the MASCPA click here.

 

 

Emma International

Emma International

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
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Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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