Regulatory Services

Comprehensive Regulatory Services Tailored to Your Needs

Regulatory compliance is a cornerstone of successful medical device commercialisation in the EU. Aequum offers end-to-end regulatory services, helping manufacturers navigate the stringent requirements set out by the MDR and IVDR. From early-stage regulatory strategy development to ongoing compliance management, our expert team provides tailored solutions to ensure your products meet EU standards.

We assist with regulatory submissions, technical documentation, clinical evaluations, and risk management plans, making the process as seamless as possible for you. Our expertise in working with notified bodies and EU authorities ensures that your product reaches the market efficiently, minimising delays and mitigating risks.

Key Regulatory Services Include:

We are ready to be your ideal partner for achieving and
maintaining compliance in the European medical device market.