Spring is off to a great start for EMMA International! We are beginning this spring season by offering a new, unique service to those looking to find direction for their quality and regulatory needs. If you’re not sure where you stand with a project, your innovative idea, or whether you should seek ISO certification, for example, but don’t want to dive right into a costly venture right off the bat, seeking this guidance from EMMA International Consulting Group, Inc. with our initial Quality and Regulatory Review Consultations is just the answer.

Quality and Regulatory Review Consultations give you the essential pieces to start completing your regulatory or quality goals so you can move forward with a better understanding of what it is you need to accomplish to maintain or acquire regulatory compliance. In this ever-changing industry, adapting to the needs of our clients is a must, but also offering services at competitive prices.

Quality and Regulatory Review Consultations range from $125-$250 and will enable our clients to get their needs assessed at a reasonable fee before leaping into a complex, costly project.

Our wide scope of knowledge and decades of experience in quality and regulatory matters and our friendly, personal approach makes EMMA International the best “one-stop shop” for seeking answers in industries such as biotechnology, medical devices, pharmaceuticals, or biologics, to list a few.

We will take a look into your quality management system, evaluate your specific needs, and answer your questions, while giving you the opportunity to clearly understand the direction you should take your business, so contact us today for your Quality or Regulatory Review consultation and get moving this spring in the right direction with EMMA International. 

 

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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