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    • New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR

      MDCG guidance on NB designation timeframes leave open capacity questions

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      FDA's Breakthrough Devices Program shows steady increase in designations

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HealthTech

Tech companies are bringing consumer-oriented connected health solutions to the regulated device market. We help tech firms design, implement, and run quality and risk management, clinical research, usability studies, and more.

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Our Expertise

Regulatory strategy

Leverage approvals in key markets to expand globally. We’ll design a regulatory and quality strategy that takes your product to established and emerging markets worldwide.

RA/QA business process services

Leverage our expertise while maintaining a lean, agile business. We can manage all your regulatory and quality operations.

Post-market compliance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Related News and Resources

The latest industry insights from our global team.

Regulatory Updates
Wiklund’s perspective: Effective user interface design versus curiosity

Fri Jul 15

Regulatory Updates
Wiklund's Perspective: IFU designers--helping us get through the pandemic

Mon Jun 20

Regulatory Updates
Considerations for post-HF validation design changes

Tue May 31

Webinars
MDR and Annex XIV: the Crucial Role of Clinical Evaluation Reports

Thu May 19

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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.