Medical devices, in vitro diagnostics, advanced therapies, etc.
We support you on all issues of compliance, quality, regulation and product/marketing strategy development.
Here are some recurring issues where we can provide value-added assistance. Learn more about our approach and how we address these issues:
I want to outsource the quality control manager position. Is this possible and reasonable with regards to my notified body?
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?
How can I use the post-market surveillance strategic tool?
I am manufacturer of medical devices. Must I validate the software that I use in my production, preparation service and control activities?
I am a manufacturer of medical devices. Must I set up a regulatory monitoring system within my company?
Does the classification of my device have an impact on placing it on the marketing?
How can I demonstrate the compliance of my electro-medical device with EN 60601-1 ed.3 in a very short time?
How important is the validation of special processes? Why do we validate special processes?
Management of subcontractors
I subcontract a large part of my activities to specialised subcontractors. How can I control them and make sure they are working properly?
I have to perform a clinical evaluation of my medical device (MD). How do I do this?
I have just taken over the management of a business. How can I get an objective view of its internal operations?
I want to register my products in the US, Canada and / or Australia. How do I do it?
Management of changes in manufacturing process
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?
How can I optimise submissions for a MD that I want to market in different countries?
Design and develop
I want to develop a medical device. What steps should I take to optimise the design of my new product?
Technical file - STED
I have to design a medical device. How to demonstrate regulatory compliance?