In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD. 

Who is Maria Diez? 

María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience in the field. Holding a Ph.D. in Biochemistry and Molecular Biology, María has specialized in developing and maintaining Quality Management Systems (QMS) in compliance with standards such as ISO 13485, ISO 14971, and IEC 62304. She also brings extensive expertise in ensuring compliance with international medical device regulations, including those of the FDA, MDR, and IVDR. Additionally, María has significant experience in integrating advanced technologies, such as Artificial Intelligence (AI) and cybersecurity, into medical device software (MDSW) and Software as a Medical Device (SaMD). 

Currently, María serves as a QA/RA Consultant at CMG MedDev, where she assists medical device manufacturers in bringing safe and effective products to market. Her expertise includes preparing technical documentation for CE marking, managing regulatory submissions for non-European markets, and helping companies navigate evolving global regulatory landscapes. María's passion for education and innovation drives her active participation in industry conferences, where she shares her knowledge on AI-based MDSW/SaMD development and her experiences as a PRRC during the certification process. 

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. 

Link

Maria Diez LinkedIn: www.linkedin.com/in/maría-diez-zaera-46460323 

CMGMedDev website: https://www.linkedin.com/company/cmgmeddev/posts/ 

PCCP guidance US:  

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices 

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