Validation & Supplier Management in MedTech
Thu Feb 05 2026
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.
Key topics discussed include:
Test Method Validation: definition, regulatory expectations, and when it is required
FDA warning letters and the risks of non-compliant validation approaches
Common pitfalls and best practices for Test Method Validation
Process Validation and Packaging Validation
The role of statistics in MedTech, including sample size justification
Risk management linked to validation activities
Supplier management, from sourcing components to audits and long-term supplier development
Simon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:
Process validation and equipment qualification
Test Method Validation training
ISO 13485 and 21 CFR 820.30 compliance
Supply chain development, including injection molding and cleanroom manufacturing environments
This episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com
If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.
Link
Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/
Social Media to follow
Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice
More
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development. Key topics discussed include: Test Method Validation: definition, regulatory expectations, and when it is required FDA warning letters and the risks of non-compliant validation approaches Common pitfalls and best practices for Test Method Validation Process Validation and Packaging Validation The role of statistics in MedTech, including sample size justification Risk management linked to validation activities Supplier management, from sourcing components to audits and long-term supplier development Simon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on: Process validation and equipment qualification Test Method Validation training ISO 13485 and 21 CFR 820.30 compliance Supply chain development, including injection molding and cleanroom manufacturing environments This episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well. Link Simon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice