ISO 13485

As a software agency, Applover is constantly seeking new ways to ensure our products meet the highest quality standards. To that end, we are thrilled to announce that we have achieved ISO 13485 certification! This milestone cements our commitment to our clients, particularly within the HealthTech sector, and assures them of our dedication to delivering premium, reliable, and secure software solutions.

What is ISO 13485 certification?

ISO 13485 is an internationally recognized standard for quality management systems in the medical devices industry. It lays out the requirements for a comprehensive management system to design and manufacture medical devices. Obtaining this certification is a testament to our ability to meet customer expectations and regulatory requirements consistently.

Is ISO 13485 mandatory?

While ISO 13485 certification is not legally mandatory, it is often seen as a benchmark for companies operating within the medical industry. This certification signifies a company’s commitment to quality, reliability, and safety in designing and implementing medical devices and related services. Furthermore, many health institutions and businesses prefer to work with ISO 13485-certified companies, underlining its critical importance in the HealthTech landscape.

How to implement ISO 13485?

Implementing ISO 13485 involves a comprehensive audit of a company’s processes, resources, and operations to ensure they meet the stringent criteria of the standard. This process includes:

1. Developing a quality system that satisfies the requirements of the ISO 13485 standard.
2. Implementing processes for risk management to ensure regulatory compliance.
3. Establishing protocols for handling customer feedback and corrective and preventive actions.
4. Regularly reviewing and improving the system to uphold and enhance its effectiveness.

We, at Applover, dedicated our efforts to this rigorous process to guarantee we’re not only complying with the highest international standards but also delivering the best quality solutions for our clients.