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...
10 signs that your company needs outsourcing
Today, Spanish organizations operate in an increasingly demanding environment and, according to Intrum's European Payment Report, more than 75% of...
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...
What are the essential ISO standards in the healthcare sector?
In a sector as regulated as healthcare, complying with international quality and safety standards is not optional: it is a necessity. ISO standards...
GMP in transformation: what do the new drafts of Chapter 4, Annex 11, and Annex 22 tell us?
In recent months, the pharmaceutical regulated sector has witnessed an unprecedented process of regulatory update. The draft versions of Chapter 4, ...
From ticket to root cause: how to connect ITSM and ITOM to reduce resolution times
When a user opens a ticket because an application is not responding, the problem may have started much earlier.
In this article, we analyze how the...
Ambit Iberia and Applus+ Laboratories join forces to drive innovation in Life Sciences
“The collaboration combines Ambit Iberia's experience in specialized consulting for Life Sciences with the technical and regulatory capacity of...
Which type of personnel selection suits you best? Clear guide, comparison, and examples
Recruitment is a strategic pillar for any organisation. There are various models and approaches for attracting, assessing and hiring talent. However,...
Expert guidance as a key factor in the medical device lifecycle
The success of a medical device does not depend solely on its technological innovation, but on how its regulatory and quality compliance is managed...
Barcelona, Capital of Digital Talent: How to Ride the Growth Wave
Over the last decade, Barcelona has positioned itself as one of Europe's most dynamic tech epicenters. Thanks to a unique combination of quality of...