Digital Transformation
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5 advantages of automation in the veterinary industry (ADS) for commercialization
Commercial process automation is increasingly present in the veterinary industry, and for good reason. Its obvious benefits make it a pressing need...
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Tools and Technologies to Improve IT Security
Cybersecurity is an essential priority in the digital era due to the growing number of cyber threats. Protecting an organization’s systems and data...
The impact of outsourcing on digital transformation in the Life Science sector
Digital transformation is redefining how the Life Science sector operates. From advances in medical innovation to regulatory process optimization,...
Artificial intelligence in medical devices: The most updated guidelines
The use of artificial intelligence (AI) in medical devices has grown significantly, driving advances in diagnosis, monitoring, and patient treatment....
Qualification vs. validation: The guide you need to distinguish them
Computer system validation and equipment qualification are fundamental requirements that determine the success of your pharmaceutical company. In...
Quality management in medical devices: Everything you need to know
In today's dynamic business world, quality management is a fundamental pillar to ensure that your products and services meet the highest standards.
Identity and access management (IAM): The key to your digital security
Implementing a robust identity and access management (IAM) solution is fundamental to protecting the digital assets of any modern organization. But...
Data integrity: Practical guide to compliance
Maintaining data integrity in the Life Sciences sector is essential to ensuring the reliability, accuracy and traceability of the information used in...
IT infrastructure qualification: Strategic pillar of digital transformation
When we talk about digital transformation, attention usually focuses on innovative applications, artificial intelligence, or automation. But there is...
Stories that inspire, technology that transforms: Partner Insights 2025 has arrived
At Ambit Iberia, we firmly believe that true progress occurs when innovation is combined with collaboration. Under this premise, we launch the second...
ISO 13485: The key standard for safety and quality in medical devices
In a sector as critical as medical devices, patient safety and regulatory compliance are absolute priorities. Therefore, having a specific and...
Why conducting a Gap Analysis in medical devices is key
In a highly regulated environment such as medical devices, staying up to date with regulatory requirements is essential to guarantee market access...
From idea to market: how to accelerate your SaMD development while complying with MDR
Developing Software as a Medical Device (SaMD) involves much more than a good idea and a brilliant technical team. Success in the European market...
Rule 11 and AI Act: strategic classification of medical software
The revision of the MDR (Medical Device Regulation) rewrites Rule 11 and the European Artificial Intelligence Act (AI Act) already has a definitive...
La nueva ICH E6(R3): Por qué la validación en entornos GCP ya no es opcional
As of July 23, 2025, the new version of the ICH E6(R3) guideline comes into force, a key document marking a before and after in how clinical studies...