Certification Experts Expands its Services with the Acquisition of CEpartner4U

Published in: General
Published on: 26 July 2024

Certification Experts, a Business Unit of Kader Group, is making a significant move to strengthen its position in the medical devices sector through the acquisition of CEpartner4U and its subsidiary, UKCApartner4U. This leading provider of advisory services related to CE marking and Authorised Representation brings valuable expertise to our Business Unit.

CEpartner4U joins Certification Experts

Optimising your Compliance through Integration

Certification Experts has firmly established itself as an authority in the application of European medical device regulations and as an Authorised Representative in the EU and the UK. The recent acquisition of CEpartner4U and its subsidiary UKCApartner4U expands our client base significantly, allowing the Certification Experts business unit, in collaboration with CEpartner4U, to serve hundreds of clients as Authorised Representatives. The combined entity will act as a powerhouse for CE marking, quality systems, and all aspects of product compliance related to medical devices and in-vitro diagnostic devices.  

“The acquisition of CEpartner4U is the second acquisition we are announcing this month and marks a milestone for our organisation. It enables us to support our clients even better in ensuring quality and regulatory compliance while promoting a safe and sustainable working environment.” – Herman Heller, CEO Kader Group 

Expanding Services and Innovation through Integration  

With the addition of CEpartner4U and its subsidiary UKCApartner4U, Certification Experts will be even more effective in assisting clients with regulatory compliance and the implementation of ISO 13485 quality systems. Not only will Certification Experts and CEpartner4U serve a broader client base, but they can now also support in-vitro diagnostic medical devices. In addition to serving as Authorised Representatives for the EU and the UK, CEpartner4U now offers CH REP services for Switzerland. While CEpartner4U excels in its role as an Authorised Representative, the expertise of Certification Experts enhances consultancy services for entities within the medical sector.

This integration strengthens Kader Group’s position as a leading player in the sector and offers clients a broader range of services. Kader Group, CEpartner4U, UKCApartner4U, and Certification Experts look forward to the benefits that the expanded service offerings from this acquisition will bring.

“With CEpartner4U joining Certification Experts, new doors are opening. We can enhance our solutions and better support our clients in regulatory compliance and market access.” – Siebren Burghgraef, Operational Manager Certification Experts 

About CEpartner4U and UKCApartner4U

CEpartner4U has over 25 years of experience advising manufacturers on complex European regulations for medical devices and acting as an Authorised Representative in Europe, the UK, and Switzerland. In addition to extensive knowledge of the Medical Device Regulation (MDR), CEpartner4U also has expertise in the In-Vitro Diagnostic Regulation (IVDR). Since January 1, 2021, manufacturers outside the UK are required to appoint a UK Responsible Person. To meet this need, CEpartner4U established its subsidiary, UKCApartner4U, which provides this service in close cooperation with CEpartner4U. Additionally, CEpartner4U offers tailored solutions to simplify compliance and accelerate market access. The CEpartner4U team consists of 6 employees.  

“We are very excited about joining Kader Group! This creates great opportunities to further enhance our solutions and support our clients even better in their regulatory compliance and market access!” Ton Pennings, Director CEpartner4U  

About Certification Experts

Certification Experts, a Business Unit of Kader Group, falls under the Consultancy & Interim services. Kader Group itself comprises 400 passionate employees and partners. Since 1995, Certification Experts has supported companies in entering new markets while ensuring product safety and has been part of Kader Group since 2022. We offer customized solutions and compliance services across the full spectrum of product safety. With CE marking, US and Canadian compliance, and as an Authorised Representative in Europe and the UK, we assist designers, manufacturers, and importers in accessing their target markets. Our expertise combines technical and legal knowledge applied to product safety, quality management, and technical documentation.

“We are thrilled and proud to announce that CEpartner4U is now part of our group. This addition strengthens our Authorised Representative and Medical Consultancy services. With a relationship spanning over 10 years, this is a natural and strategic step. It aligns perfectly with our growth goals to be a reliable and strong AR and consultancy partner and enables us to optimally serve both existing and new international clients.” Ferry van Bergen Henegouw, Business Unit Manager Certification Experts  

More Information and Contact 

Do you need an Authorised Representative in Europe (EU REP), the United Kingdom (UKRP), and/or Switzerland (CH REP)? Or do you need help with regulatory compliance and/or implementing an ISO 13485 quality system? Feel free to contact us for a no-obligation consultation and discover how we can support your organization. 

Ferry van Bergen Henegouw 
BU Manager Certification Experts 

fvbh@certification-experts.com   

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