Let’s identify our 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?

I have to design a medical device. How to demonstrate regulatory compliance?

I want to develop a medical device. What steps should I take to optimise the design of my new product?

I am a medical device manufacturer. Must I set up a regulatory monitoring system within my company?

How can I optimise submissions for a MD that I want to market in different countries?

How important is the validation of special processes? Why do we validate special processes?

My production subcontractor informs me of a change in its manufacturing process and sends me its validation change file. Should I inform my notified body?

I want to register my products in the US, Canada and / or Australia. How do I do it?

I have just taken over the management of a business. How can I get an objective view of its internal operations?

I have to perform a clinical evaluation of my medical device (MD). How do I do this?

Does the classification of my device have an impact on placing it on the marketing?

I subcontract a large part of my activities to specialised subcontractors. How can I control them and make sure they are working properly?

I am manufacturer of medical devices. Must I validate the software that I use in my production, preparation service and control activities?

I have to demonstrate the compliance of my electro-medical device with EN 60601-1 ed.3 in a very short time and in order to sell it worldwide. How can I do so?

How ca I use post-market surveillance strategic tool?

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?