Our Services

Our medical device regulatory consulting services provide comprehensive support to help you navigate the complex and ever-changing landscape of medical device regulations. We have a deep understanding of regulatory requirements and can help ensure your medical devices comply with all relevant global regulations.

Our services include:

Regulatory strategy development 

We collaborate closely with you to develop a customized regulatory strategy that aligns with your unique business needs.  This includes identifying potential regulatory challenges and recommending effective approaches to overcome them.

Regulatory submissions

We author organized and comprehensive regulatory submissions, including 510(k), PMA, CE Mark, and UKCA Mark applications, and provide ongoing support  

throughout the review process. Our expertise spans across a diverse array of medical devices, including Software as a Medical Device (SaMD) and artificial intelligence/machine learning-enabled devices. 

Quality management system

We can assist you in the establishment of a quality management system that meets the requirements of the US FDA Quality System Regulation, ISO 13485, and other relevant standards.

Labeling and advertising review 

We review product labeling and advertising materials to ensure compliance with applicable regulations.

Training and education

We offer training and education on medical device regulations to help your team stay up-to-date and compliant.

Overall, our medical device regulatory consulting services provide comprehensive support to ensure your medical devices meet all relevant regulatory requirements, allowing you to focus on your core business activities and accelerate your path to market.