Credibility for a Start-up with a QMS Certificate

Buddy Healthcare Ltd Oy

Jarmo Takkunen, Quality and Regulatory affairs

Kasve supported us in building up the EN ISO 13485 compliant Quality Management System and developed our internal auditing further. The Quality Management System takes into account the new EU Medical Device Regulation, the MDR. The work done speeds up our way to internationalization.

QMS Certificate brings competitive advantage for a start-up

Our primary goal was to act as a reckoned and credible operator in international markets. The ISO 13485 compliant Quality Management System was identified to be the key factor to bring credibility for the Company, especially in the German markets. Only few of our competitors, also small start-ups, have the ability to show the compliance for the standard by certifying the operations, which brought us direct competitive advantage.

In addition to that, our growing Company needed structured approach for the daily operations. Building up the QMS was a good justification to further improve the internal operations and built the base for further growth of the Company.

QMS enables also product development

The quality management system has brought more systematicity and structure to operations, when all the company’s practices can be easily found  and clearly documented. The availability of information has been particularly useful in product development, where it facilitates day-to-day operations. The new way of working provides the staff with better access to information and also speeds-up the orientation for new employees.

The consequences are also visible to the customer: as the testing and verification of the software product improved with the quality management system, there have been fewer errors reported by customers – that is, the quality of the product has substantially improved.

Positive comments from other companies collaborating with Kasve convinced

We wanted to be supported by a partner who would help us to target our scarce resources effectively. As a relatively small startup, we didn’t have enough time or knowledge to progress ourselves, and we felt that an outside sparrer could help us focus our efforts on things that mattered most to us. Our choice was influenced by positive comments from other companies that have worked with Kasve.

Especially in the early stages, when sparring was most needed, it felt good to have someone to turn to and who responded quickly. Together, we went through our needs and project requirements, and moved quickly forwards. We were able to create good interactions and identify those operational processes that are central to the quality management system. In addition to consulting, we utilized the ready-made templates from Kasve to describe the key contents of our processes.

We consider our cooperation successful. We got expert guidance and direction to our work, and everyone we dealt within Kasve were professionals. Overall, the six-month project was very good, and we achieved our goal: with the available resources, we achieved an exemplary quality management system and certification in accordance with the ISO 13485 standard.

We can definitely recommend Kasve to other companies in a similar situation: if there are not enough pairs of hands or know-how to build a quality management system in-house.

Buddy Healthcare Oy

Buddy Healthcare provides Mobile Care Coordination & Patient Engagement Platforms to customers to transform pre- and post-surgical care. The automatized coordination solves the most significant problems in hospitals, clinics and patients that are faced in surgeries: patient adherence to treatment, late cancellations and no-shows, administrative work and care quality. Read more: https://www.buddyhealthcare.com/en/