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We help manufacturers to achieve medical device certification and establish lean, compliant Quality Management Systems. With many years of experience in the MedTech industry, we have managed quality and regulatory affairs for both large corporations and innovative startups. As empathetic team players with a strong commitment to our work, we are dedicated to driving innovation in healthcare.
— Christoph Maier, Founder and CEO

Christoph Maier
ABOUT US

We support businesses in the MedTech industry by navigating the challenges of quality and regulatory compliance. With years of hands-on experience in both large corporations and innovative startups, we’re here to guide you through the increasingly complex regulatory landscape, ensuring your products meet applicable standards and regulations in order to get to market swiftly.

 

Our expertise spans MDR, MDSAP, ISO 13485, ISO 14971, IEC 62304, and more, and we’re passionate about keeping things lean and efficient. We focus on developing tailored solutions for regulatory affairs, quality management systems, and market access, ensuring that each step is clear and manageable.

 

Whether you're an emerging company or an industry leader, we’re committed to working with you as a team, bringing quality, compliance, and innovation into every aspect of your journey. Together, we can make a lasting impact in healthcare.

OUR SERVICES
​Regulatory Affairs​​
QMS ( Quality Management System )
MDSAP ( Medical Device Single Audit Program )
Trainings​​

​Regulatory Affairs​​

  • ​Regulatory Strategy & Planning
     

  • Preparation of Technical File
     

  • Risk Management - ISO 14971
     

  • Software File - IEC 62304​

​QMS

  • Implementation of Lean Quality Management Systems - ISO 13485
     

  • Internal- & Supplier Audits
     

  • Digital QM Systems - Enhancing efficiency through automation.
     

  • Data-Driven QM Systems and informed decision making

​MDSAP ​

  • Consultation on MDSAP requirements
    ​

  • Preparation & Gap Analysis
     

  • MDSAP implementation
     

  • Selection of Auditing Organization

Trainings​​

  • QMS Workshop - ISO 13485
     

  • ​MDSAP training - for businesses focussing on global market access
     

  • Startups: Navigate the steps to certification of medical devices
     

  • Transform your QMS with digital tools to boost efficiency

Send us a message
 and we’ll get back to you shortly.

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