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: [email protected]

 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/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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