AkknaTek GmbH: MedTech Startup implements digital quality management system

AkknaTek GmbH, a Saarbrucken-based MedTech startup, has implemented a digital quality management system. This is remarkable as interlinking business development and digital quality management at an early stage is seen as a novel approach in a startup context. The innovative move is expected to bring the company to a new level in its development. Support is provided by VENTURES, a startup program launched by DHC Business Solutions.

Cataract surgery requires exact positioning of the new lense. AkknaTek, a Saarbrucken-based startup company, has developed a unique measuring method to ensure optimal visual outcome. The approach is very promising, and the company already has received several renowned awards for its innovation.

AkknaTek, however, is breaking new ground not only in medical technology. The company is highly innovative also when it comes to managing quality and regulatory compliance. A digital quality management system according to ISO 13485 was implemented recently to avoid, from early on, awkward paper-based approaches to the management of norms, rules, and regulations and to tackle the regulatory complexity that comes with them.

Such a move is evidence of entrepreneurial foresight. “Our industry is known for regulatory complexity and high quality standards,” Dr. Edgar Janunts and Lorenz Nicolay, Founders and Managing Directors at AkknaTek, point out. “We also believe that sooner or later GxP regulations will require use of digital compliance management solutions anyway. So, for us and our young and innovative company, adopting traditional, i.e. paper-based compliance management approaches were simply out of the question.”

Support for AkknaTek’s move toward digitization in quality management was provided by the VENTURES program launched by DHC Business Solutions in 2017. The program is aimed at startups in the life sciences, the medical technology industry and other regulated sectors. Startup companies benefit from a ‘no license’ scheme for DHC VISION, DHC’s digital quality and compliance management solution. Favorable conditions for system implementation, training, and software validation services apply.

„I am very happy about our new partner AkknaTek”, Dr. Wolfgang Kraemer, Managing Director at DHC Business Solutions, emphasizes. “And deliberately I am saying ‘partner’. For what we are offering to startup companies through our VENTURES program is a long-term partnership in an area that we are very familiar with, i.e. digital quality and compliance management solutions in highly regulated environments.”

The software system DHC VISION was implemented and validated within an extremely short period of two weeks. The solution now in place at AkknaTek is expandable at any time; it provides the basis for upcoming certifications and the further growth of company operations. “We implemented DHC VISION without interruption of our daily business,” Janunts and Nicolay add. “In the meantime, the system is well-integrated in our processes. This makes it easy for us to actually ‘live’ our professional quality management system.” A pre-configured, best practice version of DHC VISION was implemented at AkknaTek with only minimal modifications. DHC’s ‘Validation Accelerators’, i.e. a set of document templates that cover the entire validation cycle, were used to validate the solution during the implementation project.

About AkknaTek

AkknaTek GmbH is a young company based in Saarbrucken, Germany, specializing in innovative measuring methods in ophtalmology. Further information is available at www.akknatek.com