🎙️ New Podcast Episode – Validation & Supplier Management in MedTech скачать в хорошем качестве

🎙️ New Podcast Episode – Validation & Supplier Management in MedTech

In this episode, Simon Foeger (SIFO MEDICAL) shares practical insights on some of the most important — and often misunderstood — topics in medical device quality and regulatory compliance. 🔍 Topics covered: • What is Test Method Validation and when is it required? • FDA warning letters and compliance risks • Process validation & packaging validation • Statistics in MedTech and sample size selection • Risk management in validation activities • Supplier management: sourcing, audits, and supplier development • ISO 13485 & 21 CFR 820.30 expectations We also discuss how SIFO MEDICAL supports manufacturers through consulting and training, including: • Equipment qualification • Online training for Test Method Validation • Supplier development in injection molding and cleanroom environments 📌 Ideal for QA/RA professionals, validation engineers, and MedTech leaders. 👉 Subscribe for more regulatory and quality insights. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video ■ Simon Foeger Linkedin:   / simonfoeger   ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance