EasyMedicalDevice.com is a consulting agency to help you navigate on the Medical Device world by providing information on the Quality, Regulatory Affairs, Compliance, and Innovation area. I'll try to make it understandable so it's easy for you to implement it. Medical Devices Regulation and technology is changing so fast. 3D printing, Medical Device mobile application. All this needs to be understood and provided with care to the patients. Each country is implementing its own regulation which can be difficult for any company to manage. The analyzes provided on this blog will help you avoid mistakes and be Right the First Time.
Great session with Michelle Lott, Harsh Thakkar and Rob Packard. We discussed about MDR seen by US Manufacturers, QMSR and its impact; And AI for medical devices in the US. So review this session here.
Some member states do not have a mechanism for issuing FSC for Article 22 systems... is there any plan to get around this? In Sweden for example Lakemedelsverke (Swedish Medical Products Agency), while not issuing a FSC, do issue a "statement letter" for Article 22 producers.. NL do not have such a process for Article 22 producers
This depends if you have a CE certificate for the sterile procedure pack. But if you do not have then the manufacturers of each products will need a free sale certificate.
I would say this is the same but maybe that process validation can be for a succession of equipment. Like validation of 3 successive equipment. And equipment validation is for 1 equipment.
