How to double your ISO 13485 certification speed with Qualio

Cardiaccs was founded in 2009 as a result of 8 years of research and development by the Intervention Centre at Oslo University Hospital in cooperation with Buskerud and Vestfold University College.

In 2014, the company received funding from the Research Council of Norway/FORNY2020 program to commercialize their Cardisense sensor technology.

The situation

Like many Class III medical device companies, Cardiaccs struggled with electronic quality management software that limited the company’s ability to manage quality documents and processes. The system was slow and provided little or no improvements in efficiency. To an extent where remote employees had to print the documents to sign and “snail mail” them back to the office.

Cardiaccs was looking to modernize their quality management and document control systems and expedite their ISO 13485 certification process.

Their existing quality management system had many problems:

• A complex interface wasted time and resources
• Major bugs and stability issues blighted engagement and task completion
• No digital signature capability hampered compliance with FDA 21 CFR Part 11
• Non-compliance with FDA 21 CFR 820

The solution

Cardiaccs hired an external quality consultant to help them evaluate new QMS applications.

They needed a system that would meet the company’s evolving quality and compliance requirements, while supporting ISO 13485 certification.

After evaluating multiple systems, Cardiaccs ultimately chose Qualio based on ease of implementation & use, and its native document workflow and digital signature capabilities, which enabled remote employees to sign and approve documents in minutes.

As promised, Cardiaccs was able to implement Qualio’s quality management software in just a few days and rapidly establish effective document controls, complete with web-based review, approval, and training built-in.

With Qualio, Cardiaccs quickly implemented best-in-class processes for:

• Design control
• Document control
• Company-wide training and compliance
• CAPAs

The result

Cardiaccs switched to Qualio in May 2015 and obtained ISO 13485 certification just six months later.

Jonas Tyssø, COO of Cardiaccs, proudly displays the company's ISO 13485 certification achieved at double speed

"Without Qualio, we couldn’t have achieved ISO 13485 certification as quickly as we did.

Going through this certification process without non-conformities is like passing a difficult exam and with the highest honors. I am so proud of the team and this remarkable result."

- Jonas Tyssø, COO, Cardiaccs

Not only was Cardiaccs able to cut its ISO 13485 certification time by 50% with no additional quality headcount spend, Qualio’s cloud-based system enabled Cardiaccs’s widely distributed team to more effectively collaborate on critical quality processes, saving the company both time and money.

For example, Cardiaccs’s remote internal audit consultant was able to complete his audit in just two hours after only 20 minutes of training. With their previous system, the consultant would have needed to perform the audit and document review on-site in conjunction with internal Cardiaccs staff, requiring four to six weeks of time.

"We now have a quality management system that is fully compliant for Class III medical devices.

With Qualio we are prepared to take the next steps towards compliance with European regulatory requirements and the CE mark!"

- Jonas Tyssø, COO, Cardiaccs

In their final ISO 13485 certification report, the assessor particularly praised Cardiaccs' CAPA processes, comprehensive risk management procedures, and robust document management and control procedures which will support the growth of the business long into the future.

See another Class III medical device Qualio customer case study