Validating manufacturing software

Validating manufacturing software

5 Dec 2019 | YOUR NEEDS

I am manufacturer of medical devices. Must I validate the software that I use in my production, preparation service and control activities? Regulatory requirement ISO 13485: 2016 specifies that the organisation must establish documented procedures for the validation...
Validating manufacturing software

Quickly demonstrating compliance with en EN 60601-1

5 Dec 2019 | YOUR NEEDS

I have to demonstrate the compliance of my electro-medical device with EN 60601-1 ed.3.1 in a very short time and in order to sell it worldwide. How can I do so? With Nex’elec, our team takes care of it for you: Select the testing laboratory that will be able to...
Validating manufacturing software

Organising post-market surveillance

5 Dec 2019 | YOUR NEEDS

How ca I use post-market surveillance strategic tool? Post-market surveillance is a regulatory requirement that can provide you with key pieces of information for risk control and corporate management. By choosing Nex’PMS, you get: Specific tools developed by...
Validating manufacturing software

Outsourcing quality control

5 Dec 2019 | YOUR NEEDS

I want to outsource the quality control manager position. Is this possible and reasonable with regards to my notified body? My company is small and we have no need for a full-time quality control manager. How can I do it? Nex’Quality enables you to outsource...

How to prepare for the DuPont Transition Tyvek

7 Aug 2017 | Process / Production

The transition from Legacy Tyvek® to Transition Tyvek® will take longer than planned. This means that manufacturers will have more time to carry it out. Discover here all the available tools to help you maintain compliance. DuPont™, the company that manufactures...