Our services in Regulatory Affairs
Technical documentation
Technical documentation is the backbone of your product development and enables future market introduction. We build solutions that are tailored to your intended use, risk class and business objectives and that also free up time and reduce the risk of costly rework.
Clinical evaluation
Clinical evaluation is not just a requirement in itself, but an essential part of your product development where scientific rigor and regulatory understanding must work together. We offer support throughout the entire process of clinical evaluation of medical devices.
Market access
Bringing a new or updated product to the global market is an essential step for many of our clients. We help interpret the requirements of the European and American markets as well as other global market segments. Produce and present relevant documentation, and support with regulatory contact or contact with local representatives during the process.
Regulatory intelligence
Regulatory intelligence is about staying ahead in a world where regulations are constantly changing. With our business intelligence process and an internal regulatory database, updates are identified early. We customize the level of intelligence as needed - from continuous monitoring to one-offs for new markets or product updates.
Post market surveillance
Post-market surveillance ensures that medical devices remain safe and perform after market entry. We help interpret regulations and establish procedures that ensure the right information is collected and evaluated in a timely manner.
Own production
We offer support in the planning, preparation and operational implementation of developing processes and procedures for in-house manufacturing. We help interpret the MDR and IVDR from the perspective of your business and provide answers on what is required and how to implement it.
PRRC
Acts as Person Responsible for Regulatory Compliance (PRRC) and conducts post-market surveillance of medical devices.
Product safety and test
We have extensive experience in developing test strategy, performing tests or coordinating with test houses to test compliance with relevant product standards.
Medical device software
We are experts in both embedded medical software and software as a medical device. Our specialists will guide you through the evolving software regulatory landscape and have the experience to combine regulatory best practice with understanding and expertise in software development
Our Compliance Partner service gives you access to the expertise you need most, in the right Location, at the right time.
Projects that really deliver on next level level change management from start to finish.
With our Academy, we offer relevant and Customised courses that meet both today's and tomorrow's needs in Life Science.
