Spring Cleaning: Don’t Forget the Cobwebs in Your Regulatory Files

by | Mar 15, 2017 | Gene and Cell Therapies, Medical Devices, Pharmaceuticals

This is the time of year when many of us tend to retake stock of our homes and lives – we clear the cobwebs, file our taxes, plan our vacations, and generally organize ourselves. So, too, should we reevaluate and organize our company’s status pertaining to a quality, compliance, or regulatory ‘clean-up.’

Have you checked your CE technical files lately? Have you made design, packaging, or sterilization changes to your devices?  When was the last time you updated your files to incorporate those changes?

If you have accumulated Letters-to-File, need a ‘catch up’ 510(k) submitted, or just need help following the most recent changes to FDA regulations in your company, you should consider the regulatory and compliance services offered by EMMA. International to manage these projects for you.

Our initial Quality and Regulatory Review Consultations can give you an idea about what it is that you need accomplished in these areas to hit the ground running in this new season, and move forward with no cobwebs or dust-bunnies lingering in your business.

Have you submitted your non-significant changes to Health Canada along with your annual renewal? Did you even know that you had to? EMMA International is a multi-national corporation with expert consultants available globally for your quality and compliance needs.

Your regulatory department is way too busy getting new products out the door to handle a lot of these regulatory actions. Let EMMA International come and do the cleaning for you. Our job is to make your life easier and help you stay in compliance with regulatory agencies. It’s always better and more economical to be proactive and in compliance than it is to respond to audit findings and warning letters. Call us for an initial Quality or Regulatory Review Consultation or to discuss a proposal with our management team.

 

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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