Field of expertise
We support you with global challenges in Regulatory Affairs and Quality Assurance
The medical device and IVD regulations are becoming increasingly difficult. It will be hard to deal with the changed requirements for medical device and IVD regulatory compliance. You might have experienced this in your latest audits or submissions. Regulatory compliance has always been around, it now simply pushed to a new and higher level. That has implications for your Regulatory Affairs, Quality Assurance and Clinical Department.
REGULATION
Global Market Strategy for MedTech Companies
What it constitutes is that the manufacturer will have duties to comply with regulations, either in the US (FDA, PMA, 510K), EU (CE), China (NMPA), or other markets. All these regulations have their own specific requirements, we fully understand complex national regulations and where they overlap. In order to reach or stay in compliance, you will have to build or update technical documentation. A Notified Body, FDA, CFDA other competent authorities will review your technical documentation and verify if it is in compliance with the medical device regulations.
Are you able to stay in compliance?
We will develop customized regulatory strategies that leverage your existing registrations. You can use Qserve as a flexible shell to support your short term or long term projects. It can be in the form of hands-on resources or in the form of RA/QA interim management: our Regulatory affairs experts fill in specific expertise that you do not (yet) have within your team.