Medical devices startup Akmelogi builds their QMS from zero with Scilife 

About Akmelogi

Akmelogi S.M.P.C was established in 2014 in Athens as a consulting firm for research and development. Since then, the company has successfully completed several challenging projects and gained expertise in a broad range of innovative solutions in the field of mechanical engineering. These solutions include the development of high-tech machinery and flexible production systems. Their mission is to provide cutting-edge innovations to clients using advanced technology and scientific knowledge.

Shortly after implementing Scilife as their eQMS, Athanasios Batagiannis, General Manager, and Maria Sarkiri, Biomedical and Quality Manager, virtually met with Fabiola Samueli, Customer Success Representative at Scilife, to discuss their onboarding experience. 

The Search

As a medical devices company, Akmelogi was searching for a quality management system that meets the standards of ISO 13485. Recognizing the ongoing shift towards digitalization, Maria emphasized the importance of integrating an eQMS to future-proof their operations and align with emerging trends. Athanasios added that:

“We pride ourselves on being tech-savvy, utilizing cloud software extensively, and keeping our workspace paper-free. Scilife’s eQMS fits seamlessly into our workflow, offering just the right structure and functionality to meet our needs efficiently.”

As a passionate advocate for environmental sustainability, Athanasios emphasized the profound benefits of embracing an eQMS over a traditional paper-based approach. In his own words:

“In our forthcoming SDG report, we will proudly highlight our eco-conscious practices, notably the minimal use of paper, thanks to Scilife’s eQMS.”

Choosing Scilife was a strategic decision to help Akmelogi's sustainability efforts of reducing paper consumption and improving operational efficiency. Furthermore, Athanasios noted that a thorough evaluation of Scilife revealed it to be the most worthwhile investment. He highlights:

"We did a cost-benefit analysis, and we really like how everything is connected on Scilife. It makes it easy to produce an audit trail and access necessary information quickly."

The Set Up

As a startup, Akmelogi faced a minimal data migration challenge when transitioning to Scilife, due to the limited amount of accumulated data. They methodically established a foundation, creating new records and SOPs from the get-go, building their QMS from the ground up on the Scilife platform. Maria expressed a positive working experience with Scilife: 

"We're very, very satisfied with the onboarding process. Both Andrea and Catherine were not only helpful but also exceptionally kind and present. They promptly addressed our questions and doubts.”

In addition to praising the outstanding customer service they received from Scilife, Maria and Athanasios found the wide range of training materials provided to be very clear and intuitive, ensuring a smooth and easy onboarding process. Maria emphasized: 

“The inclusion of videos, in addition to written instructions, was particularly beneficial in enhancing our understanding. Additionally, there's the Scilife Academy, where one can access all the articles and videos to refresh what was learned during the onboarding process.” 

Finally, Maria highlighted the invaluable benefit of Scilife's testing environment, helping Akmelogi adapt seamlessly to their new eQMS: 

“The testing environment allows you to experiment freely, gaining hands-on experience with functions. When you're in the industry, this knowledge application in the production environment not only saves time but also prevents potential issues.” 

Favorite Features

When asked about their favorite features, both Maria and Athanasios shared several features that enhanced processes at Akmelogi. Among Athanasios' top choices were Scilife's search filters, which enabled him to find documents more quickly and save time, as well as the electronic signature feature. In his own words: 

“Electronic signatures have clearly been the most useful feature for us because they save a lot of time compared to doing things manually on paper and scanning documents.”

On the other hand, Maria's standout feature preference was live document tracking which not only keeps her in the loop about the latest developments but also enhances her ability to stay informed and responsive in a dynamic work environment. She explains:

"I also like that multiple users can collaborate on a single document. Knowing who is doing what and when, along with the comprehensive tracking, proves beneficial not only for future audits but also for internal awareness of ongoing activities."

Expert Advice

A major takeaway from the onboarding process for Akmelogi was the importance of outlining a well-defined plan when implementing an eQMS. Before uploading and creating new documents, Maria recommends other organizations ensure they have set the module settings first. She calls attention to: 

"We encountered an issue with numbering and naming because we didn't define the settings before using the module and inputting our files and data. Scilife's support team rapidly assisted us in resolving the issue, but it's good practice to ensure you have the right settings beforehand."

The Results

Overall, Akmelogi found Scilife highly practical, and the functions they have used so far have proven very effective. Although they haven't tried the other modules except Document Control, they look forward to exploring new modules in the future. The prospect of using the linking function across different modules has particularly captured their interest, recognizing its utility in efficiently managing events or changes.

Furthermore, they are impressed by the diverse range of training opportunities that Scilife offers to its users, which they find particularly useful as a young and growing company.