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 Holmes, Vice President of Nidacon.

They are selling to customers in the whole world via distributors to IVF clinics. With SEK 27 million in annual sales and despite big 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 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 quality management systems for medical devices, applies to Nidacon.

− The standard contains a paragraph called ‘Control of documents’ and you might
say that 
that is what led us to contact CANEA, explains Anders Edvardsson, Administrative Coordinator at Nidacon, and 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 a growing number
of employees, 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 can 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 and case management modules in CANEA ONE. When Magda 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 a lot 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 an even greater use, says Magda 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 mindset “There is no doubt that changes can be made to the system if we need them” 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.