Consulting in Regulatory Affairs
Regulations change constantly so staying up to date is a labour-intensive job. With QbD Group as your reliant partner, you can rest assured that you get the latest information and the newest insights. Whether you only have one specific question or 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 Regulations
Due to our wealth of experience, QbD’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.
Training
Learn from the experts!
QbD Group 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, we teach you how to do so.
Classification products
The 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.
QbD 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.
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!
QbD reviews whether all general safety and performance requirements (IVDR/MDR) are fulfilled.
Label optimization allows manufacturers to save a lot of money by reducing unnecessary translations.
Scientific validity reports
IVD-R 2017/746 requires that 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.
We have written more than 100 scientific validity reports on various markers for companies worldwide. The report is entirely based on a systematic literature study and follows the IVDR requirements.
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.
Gap analysis of QMS
Does your Quality Management System match all the requirements as set out in the Regulation?
We have 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.
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 will be well-prepared and could potentially avoid remarks.
Performance studies for IVD
Stressed to test your products? Let us take care of it for you!
We manage your Clinical and Analytical performance studies according to the ISO 20916:2019 standard in close collaboration with Europe’s most renowned evaluations centers.
Review and composition of Technical Documentation
By having experts review your technical documentation to verify compliance to all the applicable requirements, you facilitate your market introduction. We identify possible gaps so they can be addressed before the Notified Body assessment.
QbD has assisted hundreds of companies to obtain their CE mark. An experience you can count on!
Authorized Representative services
As Authorized Representative for non-EU, non-UK, or non-Switzerland based manufacturers, QbD takes the regulatory interest of its customers to heart
- We handle all the interactions with the national competent authorities.Â
- QbD assists in case of regulatory actions by authorities versus the manufacturers or products in the market.Â
- We take care of incident management: incident notification, recall, editing or field safety notices.
QbD acts as EC-REP, UKRP, and CH-REP. Â
Why QBD Group?
QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient.
With more than +500 experts in various fields including RA, QbD is your partner for regulatory advice and support.
10+ years of experience
Full life cycle support
Global presence
Best Managed Company
Contact us
Need help with your Regulatory Affairs? Don’t hesitate to get in touch.
