Thankful for YOU

Nov 20, 2021
SumaLatam

Thanksgiving is not a tradition in Argentina but it’s certainly worth borrowing and taking the opportunity to count our blessings. Happy Thanksgiving!

¿Qué exige realmente la ISO 17100 en proyectos médicos regulados?

¿Qué exige realmente la ISO 17100 en proyectos médicos regulados?

Introducción En procesos de compra y auditorías, muchas agencias mencionan certificaciones como argumento comercial. Sin embargo, pocos equipos internos comprenden qué implica realmente operar bajo la ISO 17100 en proyectos médicos regulados. En sectores como salud,...

What Does ISO 17100 Really Require in Regulated Medical Projects?

What Does ISO 17100 Really Require in Regulated Medical Projects?

Introduction In procurement processes and audits, certifications are often mentioned as marketing differentiators. However, many internal teams do not fully understand what operating under ISO 17100 in regulated medical projects actually entails. In healthcare,...

IFU Translation: Common Errors That Can Compromise Patient Safety

IFU Translation: Common Errors That Can Compromise Patient Safety

Introduction In the medical device industry, Instructions for Use (IFU) are not supplementary documents—they are integral to product safety and regulatory compliance. Inaccurate IFU translation can lead to operational misunderstandings and serious clinical risks. In...