At adjutem, we empower innovators in the medical device and in vitro diagnostic (IVD) space to confidently navigate global regulatory landscapes. As a flexible and expert-driven consultancy, we support manufacturers throughout the entire product lifecycle—from development and documentation to successful market entry and post-market compliance.


Whether you're launching a novel device or refining an existing one, our team delivers tailored regulatory strategies aligned with European MDR/IVDR requirements. We work closely with you to develop risk management files, technical documentation, clinical and performance evaluations, and submission dossiers—everything required for a smooth regulatory review.

For clients targeting Asia-Pacific (APAC) markets, we offer additional value through our local regulatory partners. These partnerships allow us to support regional submissions more effectively, helping you overcome regulatory and cultural barriers in countries such as Singapore, Malaysia, Thailand, and beyond.

Beyond regulatory compliance, we help clients during transfer to production and commercialization. This includes:

  • Finding contract manufacturing solutions
  • Quality management system implementation
  • Post-market surveillance and vigilance planning
  • Regulatory intelligence and ongoing compliance support

 




Let us help you accelerate your product's journey to market.
 With a personalized approach and global regulatory insight, we are your partner in success—today and throughout your device’s lifecycle.


 Together with our business partners we can offer a full coverage of product realization activities including development, production and regulatory services.



Reach out today to learn how we can support your next step.


 

adjutem GmbH
Myrtenweg 1
26160 Bad Zwischenahn, Germany
Phone +49 441 233 698 10
info@adjutem.com

 



 From complexity to clarity.