Announcing ISO 13485 Certification – Applover’s New Milestone

Our goal has been clear since the Applover’s beginning – to create custom software solutions that meet and exceed our client’s needs while continually innovating within the HealthTech sector. Our commitment to this mission is unwavering, and we believe it’s one of the critical factors contributing to our success.

As an integral part of our journey, we have always emphasized the importance of quality management and industry standards. Achieving internationally recognized ISO certifications has been our long-standing objective and for a good reason. These certifications, backed by the International Organization for Standardization, prove a company’s commitment to upholding the highest standards of quality and reliability in its products and services.

Now, we’re thrilled to announce a new milestone in our journey: We’ve achieved the ISO 13485 certification.

What is ISO 13485?

At its core, ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. It was developed in accordance with the requirements of the ISO 9001 system. However, its relevance extends far beyond companies producing physical medical devices. It also applies to businesses, like Applover, providing software solutions for the healthcare sector, often termed “software medical devices.”

This standard places significant emphasis on the entire lifecycle of medical devices, from design and development to production, installation, and post-market activities. But what does it indeed entail? The essence of ISO 13485 lies in ensuring a company’s ability to consistently meet customer requirements and regulatory obligations while striving to maintain and improve the effectiveness of its QMS.

It’s important to note that ISO 13485 is not merely a badge of honor; it’s a commitment to improvement. It focuses on risk management, regulatory compliance, device traceability, and control of records and documentation – all pivotal in the medical devices field. In achieving this certification, a company affirms that it has implemented a QMS that aligns with the stringent, internationally recognized best practices for medical devices and quality.

Why ISO 13485 is crucial in HealthTech?

Implementation of ISO 13485 is essential when developing applications for the medical industry. In the realm of healthcare, the stakes are exceedingly high.  All stages of medical device production are subject to strict controls and numerous regulations. The reliability, safety, and efficiency of medical software can be a matter of life and death.

With ISO, we comply with the following standards and regulations:

• PN-EN 62304:2010/A1 (Medical device software. Software life cycle processes),
• PN-EN 62304,
• PN-EN 82304-1 (Software for health. General requirements for product safety),
• PN-EN-IEC 81001-5-1 (Software used in healthcare and safety, efficiency, and security of IT systems used in healthcare. Part 5-1: Security. Product life cycle activities).

By conforming to ISO 13485, a HealthTech company demonstrates its dedication to these high stakes, ensuring that its software solutions are innovative, and practical but also safe, reliable, and compliant with global regulations. This assurance is essential for building trust among clients, medical professionals, and patients.  Adopting ISO standards helps to develop an efficient and effective quality system.

Applover’s journey to ISO 13485 certification

Getting ISO 13485 certification became one of our strategic goals for 2023 and took us six months. The first step in our journey involved a thorough understanding and interpretation of the standard requirements. We realized that ISO 13485 is about documenting procedures and implementing and maintaining a comprehensive quality system focused on continuous improvement and customer satisfaction. To that end, we sought the help of industry experts and invested heavily in training our team, ensuring everyone understood what the certification entailed.

The actual audit process was a significant milestone on this journey. External auditors reviewed our systems, processes, and records to assess compliance with the ISO 13485 standard. The audit lasted three days and went really well, without any objections from the auditor. This phase was challenging and enlightening, offering us an objective view of our operations and highlighting areas where we could further enhance our standards.

Receiving the ISO 13485 certification was a proud moment for the entire Applover team. It validated our commitment to quality, our attention to detail, and our dedication to continuous improvement. More than that, it demonstrated our commitment to our clients, showing them that we are a company that values quality, safety, and excellence above all else.

What does this certification mean for our clients?

Achieving the ISO 13485 certification is a significant milestone for Applover. It stands as a testament to maintaining the highest quality and safety standards in our HealthTech solutions. But this certification means more than just a mark of quality; it reflects our values, growth, and promise to our clients.

Firstly, our software development processes have seen substantial improvements. The ISO 13485 certification required us to implement a comprehensive Quality Management System (QMS) that focuses on risk management and process control. As a result, our software development processes have become even more streamlined, leading to better control over product quality, improved efficiency, and reduced waste.

Our QMS itself has also been substantially upgraded. It now operates under a framework that encourages continuous improvement and focuses on meeting both customer needs and applicable regulatory requirements. This upgraded system is not just about maintaining high standards; it’s about constantly seeking ways to exceed those standards. This relentless pursuit of improvement is the driving force behind our enhanced services and solutions.

Furthermore, the certification has necessitated a heightened focus on patient safety and data security, especially given the sensitive nature of information in the HealthTech sector. We’ve always prioritized these aspects, but the ISO 13485 standard has provided a rigorous framework to ensure we meet the highest safety and security standards. Our clients can now benefit from enhanced safeguards against data breaches, superior data integrity, and an overall increase in the reliability and safety of our HealthTech solutions.

A milestone has been achieved, but the journey continues

Achieving the ISO 13485 certification is a landmark achievement for Applover. It’s a testament to our unwavering commitment to excellence, our dedication to quality, and, most importantly, our promise to our clients. We set out on this journey with a vision of strengthening our ability to deliver top-notch, reliable, and safe HealthTech solutions, and this certification is a significant step towards realizing that vision.

But we’re not stopping here. This certification is not our journey’s culmination but a new beginning. It’s an encouragement to keep pushing boundaries, improving, and setting higher standards. Our commitment to the ISO 13485 standard is continuous improvement, and we’re excited to see where this path will lead us.