Blog - Buddy Healthcare

Why should healthcare providers use digital solutions that are certified medical devices?

Written by Pipsa Karioja | Sep 9, 2024 7:04:18 AM

In today’s healthcare environment, a critical question often arises: Is our care coordination platform compliant, certified, and safe to use? At Buddy Healthcare, we emphasise the importance of certified medical devices. We firmly believe that healthcare providers gain substantial benefits when they procure medical software from vendors adhering to strict regulatory standards. This focus on certification is a core element of our long-term strategy. In this blog, we share our perspective, along with those of hospital decision-makers, on the essential role regulations play in the healthcare industry.

Why is regulated software crucial for Buddy Healthcare and its customers?

Compliance and Safety:
Hospitals bear the responsibility of ensuring both patient safety and regulatory compliance. By choosing certified medical devices, they reduce the risk of using non-compliant software that may not meet essential safety and performance requirements. This significantly minimises potential legal and regulatory challenges.

Quality Assurance:

Buddy Healthcare was audited in the spring of 2025 and confirmed in June 2025 to comply with the Medical Device Regulation (MDR 2017/745) as a Class IIa medical device. These compliance milestones and certifications we have demonstrate that our platform has undergone rigorous assessment and meets the highest quality standards. Hospitals can rely on the safety, reliability, and effectiveness of our solution, reducing the risk of errors or malfunctions that could negatively impact patient care.

Risk Management:
Certified medical devices offer hospitals better risk management solutions. Our platform includes built-in risk management processes and documentation, equipping hospitals with clear guidance to identify, assess, and mitigate potential risks in care coordination activities.

Reputation and Trust:
When selecting vendors and technologies, hospitals prioritise trust and reputation. Being a certified medical device company reflects our dedication to compliance, quality, and patient safety. This also helps clinical advocates within hospitals justify the internal adoption of our software to other stakeholders.

Data Collection and Use:
Regulations limit uncertified software to basic data collection from patients. However, certified software like ours goes further by adding automation and intelligence. We leverage collected data to notify healthcare professionals and personalise patient pathways, enhancing overall care quality.

Future-Proofing:
Investing in a certified medical device platform provider offers long-term benefits, such as compliance with evolving regulations. Our platform is better positioned to adapt to future changes in use cases, healthcare regulations, and standards, providing hospitals with a sustainable solution for care coordination and patient management. 

Buddy Healthcare’s commitment to compliance

Buddy Healthcare’s care coordination platform boasts multiple certifications and compliance, including:

Our company and platform undergo regular, thorough external audits to maintain the highest standards of safety and security for our hospital clients.

By choosing Buddy Healthcare’s certified platform, hospitals can ensure they are partnering with a company committed to compliance, quality, and patient safety, securing better outcomes for both patients and healthcare providers alike.