REGULATORY ANALYSIS

We will help you to navigate the UK and EU regulatory landscape by identifying the applicable legal frameworks for your product, Our analysis clarifies your obligations, ensuring you understand the legal requirements for market access and ongoing compliance.

We provide advice and guidance on meeting the requirements for UKCA and CE marking. This includes: selecting the correct conformity assessment route, navigating interactions with notified bodies, compiling the appropriate technical documentation, and accurate labelling. 

We will help you to identify, interpret and apply the appropriate standards at National, European and International level. 

We will review your product, processes, and documentation to identify gaps or non-conformities with applicable regulations (inc. essential health, safety, and performance requirements). Subsequently we can provide practical steps to achieve and maintain full compliance or suggest opportunities for risk reduction. 

We offer internal audits, gap analysis, and pre-certification reviews aligned with ISO 9001:2015 Quality Management Systems. Our approach ensures your system is both effective and aligned with regulatory obligations, helping you build a quality-driven organisation.

We deliver tailored training sessions and workshops on UK and EU regulatory requirements, CE/UKCA marking, the standardization ecosystem, among others. Whether for your technical team or senior management, we will work with you to identify the relevant content to benefit your staff and organisation.