Regulated Environment
Keys to the Successful Commercialization of Medical Devices in the EU and USA
In a world where health innovation advances by leaps and bounds, the commercialization of medical devices presents unprecedented opportunities to...
5 Key Steps to Prepare Your Regulatory and Clinical Strategy
In the Medical Devices industry, having an efficient regulatory and clinical strategy is essential to stand out in such a competitive and regulated...
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.
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...
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...
Practical summary of the new ISPE digital validation guide
Following the publication of the new ISPE Good Practice Guide: Digital Validation, a comprehensive guide on how to adopt, implement, and govern 100%...
In-house manufacturing of medical devices as a path to innovation
¿Sabías que puedes usar tus desarrollos internos en la práctica clínica para recopilar más datos clínicos en entorno real de utilización? El artículo...
How much risk are you taking with your non-validated systems?
The pharmaceutical and biotechnology industry in Spain is going through a crucial phase marked by digital transformation, regulatory evolution, and...