nex’pms

nex’pms

6 Dec 2019 | OUR SOLUTIONS

Post-market surveillance   PMS/ PMCF: You recognise these words, and they may be sometimes familiar, but you do not really know what they mean. You are not sure what information to supply. What level of detail and analysis is expected? Are you looking for a...
Eliminating non-compliance permanently

Eliminating non-compliance permanently

6 Dec 2019 | YOUR NEEDS

The number of non-compliance issues increases with each audit and I cannot resolve them. How can I improve the efficiency of my quality control system? The solution: nex’quality At Nexialist, we process non-conformities as a team, requiring an overall...
Eliminating non-compliance permanently

Demonstrating regulatory compliance

6 Dec 2019 | YOUR NEEDS

I have to design a medical device. How to demonstrate regulatory compliance? A medical device must meet the regulation on medical devices. Regulatory compliance is to gather all the evidence to show that the device is safe and effective. Firstly, it is important to...
Eliminating non-compliance permanently

Design and development of a medical device

5 Dec 2019 | YOUR NEEDS

I want to develop a medical device. What steps should I take to optimise the design of my new product? ISO 13485:2016 specifies that the agency shall establish documented procedures for the design and development. But what does this really mean? With nex’design,...
Eliminating non-compliance permanently

Implementing regulatory monitoring

5 Dec 2019 | YOUR NEEDS

I am a medical device manufacturer. Must I set up a regulatory monitoring system within my company? Yes, it is a regulatory requirement, which also has many advantages. Nex’inform allows you to: Have an edge in your market; Save time in anticipating and making...