Consulting Services

Professional Services

You may have the following questions/concerns:

You are developing an instrument, apparatus, appliance, software, material or other article, to be used specifically for diagnostic and/or therapeutic purposes. When should you start your regulatory or quality work?
Does my device require clinical trials?
What are different requirements from different regulatory agencies worldwide?
How much non-clinical or clinical trial data is needed to support your product submission?
How do I construct my quality management system according to QSR, GMPs, MDRs, MDD or ISO 13485 requirements?
How do I put together the license application, technical file, 510K or PMA for my medical device product(s)?
How do I conduct a device recall?
How do I prepare post-marketing procedures?
How do I certify my manufacturing site for an ISO 13485:2003 certification audit?
Which certification or notified bodies do I need to contact?
What is CE Marking?
How do I train my staff to maintain the quality of operations and ensure compliance at the same time?

If you have any of the above questions, then you need Axsource Professional services.
Our services will allow you to:

Concentrate on the science & development activities and kick start your registration and licensing process with the regulatory agencies
Increase efficiency of the operations and establish your QMS
Ensure compliance of your device processes and management operations
Reduce licensing and operational cost
License your facilities and products
Assist in transfer of knowledge and expertise to your staff