Quality and Standards

As the first ISO 13485:2003 certified menstrual cup manufacturer and head office in the world, Diva International Inc. is challenging the 100 year old menstrual status quo of chemically manufactured products, disposable slogans and menstrual shame.

We believe that all women should have a happy and healthy period experience. That is why we do everything we can to ensure our products are certified, registered and manufactured with women’s health and comfort in mind.

ISO 13485:2003 Certification:

ISO management systems are governed by the International Organization of Standardization in Geneva, Switzerland, and are recognized and practiced in over 160 countries around the world. ISO 13485 is the Quality Standard Management System for medical devices and is required by Health Canada for all medical device manufacturers worldwide. It has been designed to ensure that companies follow strict guidelines for the highest quality of products and business practices, as well as meeting applicable government requirements. Our ISO certification ensures that we have a quality management system in place that will consistently meet quality expectations for our products.

Our compliance to FDA, Health Canada, Australian TGA and COFEPRIS health regulations guarantees that The DivaCup is made with the same silicone material and grade approved for healthcare applications for over fifty years and that it does not contain any of the following: latex, plastic, PVC, acrylic, acrylate, BPA, phthalate, elastomer and polyethylene and is free of colors and dyes. Silicone products have been shown to be biocompatible (i.e. accepted by the human body without adverse reaction), durable, flexible, and easy to sterilize. What’s more, our award-winning The DivaCup was the first menstrual cup approved for sale in Canada by Health Canada.

Certified B Corporation:

Diva International Inc. became a Certified B Corporation in 2018. B Corps are a new type of company that uses the power of business to solve social and environmental problems. B Corp certification is to business as what a Fair Trade certification is to coffee or USDA Organic certification is to milk. Diva International Inc. was certified by the non-profit B Lab to meet rigorous standards of social and environmental performance, accountability, and transparency. We’ve evaluated how our practices impact our employees, our community, the environment, and our customers. Today, there are over 2,200 Certified B Corps around the globe. We are proud to join them in redefining success in business, so that one day everyone uses business as a force for good. To learn more about our certification, check out our B Corp online profile.

 

How The DivaCup is made:

The DivaCup is manufactured in Canada. The silicone starts as a liquid and then the molecules are bound together (or vulcanized) with very high heat to form a solid stable piece of silicone (similar to the feel of soft rubber). The DivaCup is cured after production in an oven at a very high temperature to make sure all the molecules are bound and “chain linked” together. Since the end product is a solid material, yet flexible and durable, there is no possibility for anything to leak into the body (no leaching). Even when boiled for cleaning, the material used to manufacture The DivaCup has been tested to ensure none of the molecules will break away from the product.

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