ISO 13485/GMP Matrix for delegates

Combination products (a combination of medicinal products and medical devices) are subject to two different regulatory frameworks: ISO 13485 for the medical device component and GMP for the medicinal product component. Are there parallels and differences between the two sets of regulations? The ISO 13485/GMP matrix, based on ISO 13485, provides further assistance here. It compares and evaluates the requirements of ISO 13485 with the GMP requirements in Part I EU GMP Guideline.

As a participant in the online event “ISO 13485-Requirements for Medical Devices - Comparision to GMP” on November 25/26, 2025, you will have the opportunity to download the matrix free of charge.