Anton Kontunen is a System Engineer at Olfactomics. He has the current main focus on building and developing the quality management system alongside a regulatory and quality expert, Mika Siitonen, from Mectalent Medical Services (QualityKick partner).
As Anton has been actively involved in building the QMS at Olfactomics from the ground up, he has had the opportunity to delve deep into the world of quality and to learn immensely during the last year. By using QualityKick Anton has been able to effortlessly produce content for SOPs, Forms, Test reports and plans, etc.
State-of-the-Art Medical Device
Olfactomics is a Finnish company founded by a team of medical experts and engineers from University of Tampere. They have recently developed a state-of-the-art differential mobility spectrometer to enable rapid gas analytics in wide range of applications. Currently they are aiming to utilize its superb gas analysis capabilities in cancer margin detection by developing a medical device that can differentiate tissue types based on their surgical smoke. An ISO 13485 - certified quality management system is essential for the development of medical products. In the search for agile tools for their work, Olfactomics discovered QualityKick.
Olfactomics' challenge to find a quality solution
Olfactomics started to build up their ISO 13485 quality system the “old-fashioned” way, with printed paper documents that needed to be physically signed by the appropriate reviewers and approvers. This proved to be needlessly challenging and slow since many members in the organization conduct their work in different locations and they are not always able to print and scan various documentation. Since Olfactomics is also a relatively small company, the management and storage of a paper-based system would be a significant overhead.
QualityKick is the solution Olfactomics needed
As Olfactomics realized that a paper-based QMS is not a valid option for them, they decided to search for the best electronic alternative. After a free, two-week trial, the team was convinced that QualityKick was the right choice for them. From the get-go, they were extremely pleased that QbD software prioritizes customer satisfaction and offers continuous and swift support, when needed. The opportunity to customize the eQMS product by selecting different modules and roles for the users was also one of the key features for Olfactomics.
The Benefits of using QualityKick
With QualityKick, the management of the documentation that is needed in a medical device development project becomes controllable and certain documents can be modified with ease without ever losing the traceability of changes. In addition, it really helps the organization, when the same system also includes training records and the functionality to handle events such as audit findings or CAPAs. All in all, Olfactomics is pleased to have chosen QualityKick as the service for their eQMS.