Expertise field

Regulatory affairs for medical devices

 

The medical device regulations are becoming increasingly difficult. It will be hard to deal with the changed requirements for medical device 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 RA, QA and Clinical department.

Regulatory compliance is the overarching term for serveral activities.

What it constitutes is that the manufacturer of medical devices will have duties to comply with regulations, either in US (FDA,PMA, 510K), EU (CE), China (CFDA), or other markets. All these regulations have their own specific requirements, although there is a common basic set of essential requirements that is valid for each and every country. 

In order to reach or stay in compliance you will have to build or update technical documentation. A Notified Body, FDA, CFDA other competent autorities will review your technical documentation and verify if it is in compliance with the medical device regulations. How to prepare technical documentation, technical files, or design files is the expertise of Qserve. 

Are you able to stay in compliance?

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 interim management: our experts fill in specific expertise that you do not (yet) have within your team.

We offer support in the following areas: 

Regulatory Strategy

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

GAP-Analysis

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

Interim Management

Let our consultant temporarily be part of your team to manage regulatory compliance issues. 

Notified Body Selection

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

Registration (CE/FDA/Other)

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

Technical Dossier Set Up

Use Qserve to structure your dossier, update it or just guide you with formats and reviews.  

Post Market Activities

Also after getting market access you have to stay compliant and gather feedback on performance.  

Legal Representation

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

 

Vigilance & MDR

Qserve supports with reporting incidents and field actions in the US, Europe and other markets.

 More information about our regulatory services?

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