Buddy Healthcare has been granted ISO 13485:2016 certification for its Quality Management System (QMS). The company’s QMS was audited and certified by SGS Fimko according to the requirements of ISO 13485:2016 standard.
This is a major milestone for Buddy Healthcare. Our team has done a tremendous job in addressing all challenges with determination and persistence to get us here today, says Jarmo Takkunen, Quality & Regulatory Affairs Manager
ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. Being ISO 13485 certified means that Buddy Healthcare has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485:2016. The QMS also incorporates key features from other relevant international standards, including ISO 14971 and IEC 62304.
In the certification process auditors evaluated that Buddy Healthcare’s Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices. As an ISO 13485:2016 certified company, quality, efficacy, and safety are part of its core activities. Buddy Healthcare's personnel follow the procedures and rules required by the certification.
According to new MDR regulations, medical device platforms such as the BuddyCare Platform must obtain QMS certification. The new certification adds credibility for us in the market and a feeling of safety to our customers when purchasing and using the platform. Obtaining certificates helps us in the global markets as, for example, the Central European market very much appreciates certifications such as 13485:2016, concludes Jussi Määttä, CEO and Founder of Buddy Healthcare.
Buddy Healthcare is a European based digital health company - automating hospitals' care coordination and patient communication processes. The company was founded in 2016 and the care coordination platform was co-created in collaboration with university hospitals in Finland.
The company initially started producing intelligent and automated surgical care pathways, but it has rapidly expanded to other medical specialties. In addition to being ISO 13485:2016 certified, The BuddyCare software has the medical device class I CE mark and is GDPR and HIPAA compliant.
SGS is the world’s leading inspection, verification, testing and certification company. The company is recognized as the global benchmark for quality and integrity.