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Extra Horizon obtained ISO 13485:2016 certification to become a supplier to MDR/IVDR regulated customers

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Extra Horizon has achieved the ISO 13485:2016 certification for its quality management system. This certification demonstrates our Extra Horizon services are compliant with the international standard that specifies the requirements for providers of medical devices and related services. 

ISO 13485:2016 focuses on how companies manage and implement a risk- based approach to control and monitor processes such as purchasing, design, development, manufacturing, quality control activities and product monitoring. With the certification, Extra Horizon can demonstrate to regulators and partners that it meets the applicable regulatory requirements.

A solution accelerator 

Extra Horizon provides fully compliant and fully scalable cloud connectivity and 

GDPR-compliant data storage through a medical backend-as-a-service platform. The Extra Horizon platform delivers a medical infrastructure based on agility, global regulatory compliance and scalability with a full suite of essential functionalities.

The ISO 13485:2016 requirements had already been implemented a while back, but SGS Belgium (notified body 1639), an official certification company, has now given its formal certification after a thorough audit process.

This certification is of crucial importance to Extra Horizon because of its partnerships with pharmaceutical companies, medical device manufacturers and in vitro diagnostic (IVD) companies who, by nature of their work, operate in highly regulated environments. Extra Horizon, being a critical supplier to these medical device manufacturers, must be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users. 

The key element of risk management

Because companies are required to consider the risk associated with their products, it is vital for them that their suppliers be compliant with ISO 13485. For that reason, it was critical for Extra Horizon to be certified because ISO 13485 broadens the scope of the entire risk management process, including risk-based analysis and risk-based control. It does so by placing the burden of verification on the organization that is creating the product or service. That not only affects medical device companies, but it is also a determining factor for firms providing a critical service or a critical component to that device, as it goes to market.

The ISO certification enables Extra Horizon’s partners to focus their energies and resources on their core business, allowing them to bring their solutions to market faster and acquire the agility and flexibility they need to adapt in the ever-evolving digital health space.

 Jo Van der Auwera, Co-founder and Chief Regulatory Officer at Extra Horizon comments:

“Securing this ISO 13485 certification is another major milestone that Extra Horizon has achieved. Since COVID-19 has accelerated the growth of the digital health space, and with MDR/IVDR regulation around the corner, we're able to provide a much-needed solution for those digital health companies that face regulatory approval, by offering our medical grade backend-as-a-service.”

For more information about Extra Horizon’s ISO certification and regulatory compliance to international standards please contact us.