Regulatory Affairs


Regulatory Affairs Consulting

Regulations change constantly and to remain up-to-date is a labour-intensive job. With Qarad as your reliant partner, you can rest assure that you get the latest information and the newest insights. Whether you only have one specific question or you need the full Regulatory Affairs support, to the great satisfaction of our customers, we do it all!  

Whether you are a small, medium-sized company or a multinational, we adjust our approach to handle your regulatory affairs accordingly. 

Our services include:

  • Consulting on IVD and MD Directives and Regulations
  • Training
  • Review and composition of Technical Documentation
  • Review Instructions For Use and labels
  • Gap analysis of QMS
  • Assistance in Notified Body selection
  • Preparation for conformity assessment by Notified Body
  • Classification products
  • Performance studies for IVD
  • Scientific validity reports
  • Authorized Representative services

Consulting on IVD and MD Directives and Regulations

Due to the wealth of experience, Qarad’s consultants know the regulations from A to Z. 

We understand the impact they have on your business and operations and we help you to deal with them. 

Receive important regulatory updates immediately in your inbox.
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Training

Learn from the experts!

Qarad provides classroom, web-based or on-site training sessions according to your needs.

Whether you want to know more about the content of a certain directive or regulation, how to approach risk management or how to establish an efficient and compliant product development process, Qarad teaches you how to do so.

Click here for more information about all Qarad’s training sessions!

Review and composition of Technical Documentation

Without your professional and kind services, we would not have had our first CE mark so smoothly.

Guangzhou Wondfo Biotech

 

By having experts review your technical documentation to verify compliance to all the applicable requirements, you facilitate your market introduction. 
Qarad identifies possible gaps so they can be addressed before the Notified Body assessment.

Qarad has assisted hundreds of companies to obtain their CE mark. An experience you can count on!


 

Review Instructions For Use and labels

Compliant labelling is a must for the Notified Bodies and Competent Authorities and therefore it is a high priority for you! 

Qarad reviews whether all essential requirements (IVDD/MDD) and/or general safety and performance requirements (IVDR/MDR) are fulfilled. 

Label optimisation lets manufacturers save a lot of money by reducing unnecessary translations.

Gap analysis of QMS

Does your Quality Management System match all the requirements as set out in the Directive and/or Regulation?

Qarad has set up countless successful Quality Systems so we are the ideal partner to get you started. Alternatively, we can assess your current system and make a clear gap analysis to structure how to improve your system. 

More information about Qarad’s QMS services

 

Assistance in Notified Body selection

Notified Bodies must be designated for each particular legislation before being able to audit compliance thereof. 

As manufacturer, it is of utmost importance to know which Notified Body you should reach out to in which situation.

We help you to make a preselection of the available Notified Bodies. 


  

Preparation for conformity assessment by Notified Body

A flawless audit is something we all dream of. 

Our consultants can act as an auditor to assess conformity before the ‘real’ Notified Body audit. By doing a mock audit, you start well-prepared and could potentially avoid remarks.

 

Classification products

The directives and regulations try to explain which type of product belongs to which class. 

However, many products fall in a grey zone and you will need a correct interpretation to assess your product’s class and the related conformity assessment route you need to undertake. 

Qarad’s consultants do this on a day-to-day basis and thanks to our experience and rational reasoning, we offer a classification that will be easily defensible with your Notified Body. 

Performance studies for IVD

Stress to test your products? Let us take care of it for you!

Qarad manages your Clinical and Analytical performance studies according to the ISO 20916:2019 standard in close collaboration with Europe’s most renowned evaluations centres. 

Have your Performance Studies organized by Qarad

 

  

Scientific validity reports

IVD-R 2017/746 makes you prove the scientific validity of your IVD products. This is a very time consuming task.
Avoid this by outsourcing your scientific validity reports to our experts. 

Qarad has written more than 100 scientific validity reports for various markers for companies worldwide. The report is entirely based on a systematic literature study and follows the IVD-R requirements.

Authorized Representative services

As Authorized Representative for non-EU manufacturers, Qarad takes the regulatory interest of its customers to heart. 

  • We handle all the interactions with the national competent authorities.
  • Qarad assists in case of regulatory actions by authorities versus the manufacturers or products in the market.
  • We take care of incident management: incident notification, recall, editing or field safety notices.

Qarad acts as EC-REP. 
Click here for more information

 

Contact us for more information

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