Angel Buendia
Knowledge Manager, Scilife
With 20+ years of experience shaping quality within pharmaceuticals, Ángel bridges QC & QA expertise in life sciences. His passion for continuous learning, combined with his role as a Smart Quality advocate, drives his dedication to instilling a quality culture, guiding teams with collaborative leadership, and fostering excellence as a cornerstone. He navigates complex regulations, and is driven by upholding high standards and fueling innovation.
Medical device teams often spend months perfecting a breakthrough design. But the moment ISO 13485 certification and compliance enter the picture, momentum often grinds to a halt. The quality team has been brought in too late. Documents are scattered...
When working with medical device companies, one thing becomes very clear: the difference between a team that’s audit-ready and one that’s constantly chasing documentation often comes down to a single factor—training. If quality and compliance trainin...
Medical devices are a vast category of equipment, treatments, and functional aids, ranging from caries detection software to contact lenses, orthopedic implants, respiratory care, and more. Every person will need a medical device at some point or ano...
If we were to compare ISO 9001 vs ISO 13485, which one should you adhere to?
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