Digitization in Quality Management: Medtech startup AkknaTek ventures into the next stage

29. August 2018

Saarbrücken-based medical technology startup AkknaTek GmbH is entering the next phase of its corporate development with a digital quality management system. Funding for this comes from DHC Business Solutions’ VENTURES startup program. AkknaTek is innovative in the regulated environment due to the close connection of product and company development with early digitalization in quality management.

During surgery for cataracts, the position of the new lens must be determined precisely. For this purpose, the Saarbrücken-based medical technology startup AkknaTek GmbH is developing a special measurement method that is unique to date. A number of prizes have already been awarded for this innovation and the promising start-up. For example, it was awarded the Venture Cup at last year’s Science4Life competition and the top prize at the Digital Innovations start-up competition at CEBIT.

AkknaTek is not only breaking new ground in medical technology

The company is also innovative in the management of compliance and quality. AkknaTek has relied on digitization of its quality management system in accordance with ISO 13485 almost from the very beginning and does not even try to master all the standards, rules and regulations with paper-based documents and processes.
There is certainly commercial foresight behind this: “The requirements in our industry are high and are not expected to become less complex in the future. In addition, digitization will not stop at the GxP environment and digitized quality management systems will become inevitable sooner or later. For us as a young and innovative company, conventional forms of management are therefore already absolutely out of the question today”, says the two AkknaTek Managing Directors Dr. Edgar Janunts and Lorenz Nicolay.

AkknaTek is entering into digital quality management as part of VENTURES, DHC Business Solutions’ support program for startups in the life sciences, medical technology and other regulated industries. With VENTURES, young companies receive the DHC VISION software without license costs and with special conditions for system implementation and validation.

I am very pleased that we have been able to win AkknaTek as a new partner for our VENTURES program,” emphasizes Dr. Wolfgang Kraemer, Managing Director and partner at DHC Business Solutions. “And I say ‘partner’ deliberately. We want to support young companies in the long term and make them perform in the field in which we are experts: In digital solutions for quality and compliance management in the regulated environment”.

The DHC VISION software was implemented and validated at AkknaTek in just two weeks. This provides an expandable software solution for future certifications and further company growth. “The software was introduced in parallel with day-to-day business. Since then, DHC VISION has been integrated into our daily work and helps us to use our quality management system in practice”, says the Managing Director of AkknaTek GmbH. DHC VISION was implemented as a pre-configured “best practice” solution with minimal customization and validated using validation templates – the DHC VISION “Validation Accelerators”.

About AkknaTek:

AkknaTek GmbH is a young company specialized in the development of innovative measurement methods in the field of ophthalmology. For more information about the company, please visit: www.akknatek.com.