Regulatory Affairs

We translate medical device regulations to regulatory strategy and analyse your specific project to provide customized support. 

EXPERTISE FIELD

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.

SERVICES

We offer support in the following areas:

Global Market Access

Developing the optimal regulatory strategy depending on the device and market you want to enter.

Notified Body Support

Qserve guides you with the selection of the correct Notified Body for your specific device.

Post Market Activities

Also after getting Market Access, you have to stay compliant and gather feedback on performance.  

GAP-Analysis

Qserve reviews data to identify the gaps in compliance and provide a plan to address those.

Global Registration 

Need help to register your device in the US, Europe, China or any other country? Let us support you!

Legal Representation

Exporting and looking for a local and independent representative? Use Qserve's legal entities.

Clinical Evaluation Consulting

Worldwide regulations are focusing more and more on compliance, specifically of clinical data.

QMS Compliance

QMS Implmentation and Maintenance based on local quality system requirements.  

Auditing 

Audits are executed to determine regulatory compliance and improve the effectivity of your internal processes and those of your subcontractors and suppliers

How can we help you? Contact us