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 minimizes potential legal and regulatory challenges.
Quality Assurance:
Buddy Healthcare is certified under the Medical Device Registration (MDR) CE Class I (Medical Device Directive) and is in the process of obtaining MDR Class IIa certification. These certifications demonstrate that our platform has undergone rigorous testing and adheres to the highest quality standards. Hospitals can trust in the reliability and effectiveness of our solution, lowering the chance 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 prioritize 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 personalize patient pathways, enhancing overall care quality.
Future-Proofing:
Investing in a certified medical device platform 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 care coordination solution.
Buddy Healthcare’s commitment to compliance
Buddy Healthcare’s care coordination platform boasts multiple certifications and compliance, including:
- ISO13485:2016 - Medical Devices Quality Management Systems
- ISO27001:2022 - Information Security Management (including annual external security penetration testing)
- Medical Device Registration CE Class I (Medical Device Directive)
- Cyber Essentials Plus
- NHS Digital Technology Assessment Criteria (DTAC)
- DCB0129 - Clinical Risk Management for Health IT Systems
- Web Content Accessibility Guidelines (WCAG) 2.1
- The Organisation for the Review of Care and Health Apps (ORCHA)
Our company and platform undergo regular, thorough external audits to maintain the highest safety and security standards 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.
