Set Your New Year’s Quality and Regulatory Resolutions

by | Jan 6, 2017 | Uncategorized

First, EMMA International would like to wish everyone a wonderful and prosperous new year.  However, we know that a new year can also bring new challenges. In 2017, you can:

  • Transition from ISO 9001:2008 to ISO 9001:2015
  • Transition from ISO 13485:2003 to ISO 13485:2016
  • Get up to speed with the Medical Device Single Audit Program (MDSAP)

Don’t worry! Now is the time to start the transition and EMMA International can help every step of the way. But it is important to start now. The industry is anticipating long wait times with certified bodies, so it is important to get your renewals on the schedule now.

So, don’t stress. Let EMMA International conduct a gap analysis, help remediate the gaps, provide staff development and training and be your support throughout this process. Set your New Year’s Quality and Regulatory Resolutions with EMMA International and enjoy working with a strategic partner who will support you every step of the way!

 

For more information, please contact:
Janet Bloom, VP of Business Development
248-445-1033 or 
janet.bloom@emmainternational.com

 

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.
Is your product a medical device?

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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