Verifiable system meets high regulatory requirements

Medical device company Nidacon needed a verifiable system for document management. CANEA ONE was one of few systems that lived up to their stringent requirements.

Nidacon International AB was founded in the early 1990s and is active in a small medical device niche. They develop and manufacture medical devices for IVF (in vitro fertilization) and are best known for the product PureSperm (purifies semen for testtube fertilization).

PureSperm was the first product specially designed for IVF for people and it is still the most used product in the field,” says Magda Alic Holmes, Vice President of Nidacon.

Sales are worldwide via distributors to test-tube fertilization clinics. With SEK 27 million in annual sales and despite major interest from larger companies, Nidacon has opted to only grow organically.

A lot of small companies are acquired through takeovers these days. We value being able to focus on our core operations and our customers in the future as well. That is more important to us than growing quickly. We have the great luxury of being able to choose that option for Nidacon,” says Magda Alic Holmes.

Regulatory requirements

Medical device companies face stringent regulatory requirements for how their operations must be run. The overarching standard ISO 13485:2016, which covers the requirements for a quality management system for medical devices, applies to Nidacon.

“The standard contains a paragraph called ‘Control of documents’ and you might say that’s what led us to contact CANEA,” explains Anders Edvardsson, Administrative Coordinator at Nidacon. He continues,

We had previously taken care of document management manually, but as time passed, we felt it was becoming too challenging. As a result of our growing employee base as well as more and more documents requiring processing, we found document management deviations during checks.

The solution was CANEA ONE

CANEA ONE is a verifiable system, which few suppliers are able to offer at this point. ISO 13485 requires all software used in medical device companies’ operations to be verifiable.” says Anders Edvardsson.

At present, Nidacon uses the document management and case management system module in CANEA ONE. When Magda Alic Holmes is asked what key phrase she uses for the relatively new system, she says: resource optimization.

CANEA ONE makes our work much easier and everyone feels confident. Today, it’s much easier during an audit to show that we meet the document management requirements. We no longer have to check how everything looks before an audit; we know it’s right.

The development of the system does not stop at Nidacon simply because everything works.

I think there will be a constant stream of ideas on how to put the modules we already have to even greater use.” says Magda Alic Holmes. Anders Edvardsson agrees and says there is talk of further modules.

We don’t currently have any project management software; CANEA ONE is a strong option for an upcoming evaluation. CANEAs knowledge of the “There is no doubt that changes can be made to the system if we need them.standard makes it a faster path to a system that we know will meet all the requirements placed on us,” he says, concluding with words of praise:

The interactions I’ve had with salespeople and technicians at CANEA have always been incredibly professional and inspired confidence. There is no doubt that changes can be made to the system if we need them.

About Nidacon

Nidacon is a Swedish company headquartered in Gothenburg that manufactures medical devices, mainly for Assisted Reproduction Technologies (ART), with IVF, ICSI, artificial insemination (IUI) and vitrification solutions.