At Diva, we don’t settle. Quality assurance is a top priority for our team from how we hire through to how we ship our products to customers. Diva is the first and only globally commercialized menstrual cup that is government-approved as a class 2 medical device in seven countries and growing.

Since our start in 2001, Diva has paved the way for other menstrual cups to enter the market through our example in quality assurance and success in mainstream markets and commercialization.  

What is the secret to our success? In addition to the revolutionary nature of our award winning DivaCup, having a strong quality management system (QMS) in place ensures everything we do, is done in the best way possible. 

Curious about the role QMS plays in the menstrual care industry? Read our guide below:  

What is a Quality Management System? 

Did you know that in most countries, internal menstrual care products like menstrual cups are regulated as medical devices? Manufacturers of medical devices need to have a quality management system (QMS) in place to ensure that the products they make are safe and effective. A QMS is an organized system of business processes or rules that are guided by documented procedures, polices and records that support the production and delivery of goods or services to customers. For our customers, think of a QMS as a safety standard for your menstrual cup.  

The International Organization for Standardization (ISO) creates instructions for businesses to standardize the way products are manufactured within the highest of standards. Certification to an ISO standard is one step a company can demonstrate that it adheres to strict management practices. ISO essentially provides a set of rules for how a medical device QMS is run. Certification typically involves annual audits from an independent outside auditor that evaluates the business to ensure that instructions or requirement of the standard are being met.  

ISO 13485 is an ISO published standard that is intended for companies making medical devices. For some countries, being certified to this standard is a requirement before your product can be sold there.

ISO certification communicates excellence to both our distribution partners and customers. Both know they are receiving a product that has gone through rigorous safety checks all within the highest of standards.  

What is the MDSAP? 

For some countries, manufacturers of menstrual cups must hold an ISO 13485 certificate under the Medical Device Single Audit Program or MDSAP before a product can be sold there. The MDSAP is a program where an outside auditor will come to your place of business and conduct an audit where they go through your business from top-to-bottom with a fine-tooth comb. An MDSAP audit includes all the requirements of the ISO 13485 standard plus it looks at the requirements of the individual countries that have signed onto the program. Currently this list includes Canada, Japan, Brazil, the United States of America and Australia.  

The importance of a QMS for menstrual cups?

When selling a product that sits internally, like the DivaCup menstrual cup, ensuring the best for customer’s health is paramount!  

For our customers, our ISO Certification ensures that the DivaCup is the best menstrual cup for their health because it is made within the highest of standards, with safety and inspection checks at every level of production.

If you are new to menstrual cups, make sure the manufacturer of the cup (or any medical device) you are purchasing complies with the regulations specific to your country. Menstrual cups are medical devices in some countries, but not all, so if you are in a country where the regulations are not as stringent, consider purchasing a cup from a manufacturer that meets the highest standards like the DivaCup and be sure that the company has an ISO 13485 certification.  

At Diva International, we are certified to the latest edition of the ISO 13485 standard under the MDSAP. We also make sure that the DivaCup exceeds safety standards required for menstrual cups in the jurisdictions we sell into. This includes proper labeling, instructions, and customer service requirements. We also ensure our suppliers meet the same requirements as well.