My wish is to support the needs of pharmaceutical and medical devices companies to reach their objectives and to help patients to obtain the product they need. I've acquired during my career sufficient knowledge to drive projects related to quality and regulatory affairs and had experienced many successes but also some difficulties which helped me to learn more.To start that journey I created EasyMedicalDevice.com which is here to bring some awareness on all the new regulations transitions that are ongoing.As you can see by the name of the site, the objective is to make the Medical Device Regulations and Standards easy to understand. Read my blog posts and look at my Youtube channel and subscribe to my podcast (Medical Device made Easy) so you can learn how to place a compliant medical device on the market.My Motto is: "WOULD I GIVE THIS PRODUCT TO A MEMBER OF MY FAMILY?" so don't forget that health is one of the most important pieces of your life. Don't destroy it.About me:For my background, I am specialized in Quality and Regulatory Affairs for Medical Devices and also have some experience in Medicinal Products. This helped me to acquire knowledge of combination products and borderline products.Below are some of the standards and regulations I practiced:For devices - Medical Device Directive MDR 2017/745, IVDR 2017/746, MDD 93/42/EC, 98/79/EC for IVD, FDA 21CFR 820, ANVISA, JPAL and 510K registration, ISO 13485:2016, ISO 14971.Related to drug - I follow Drug Directive 2001/83/EC.Additionally, I drove some Process improvement (Change management, PDCA, CAPA)Lean manufacturing (SMED (Pit stop), Value Stream Mapping, 5S, 6 sigmas)