A robust Technical Documentation (TD) is crucial for any market authorisation process and is often subject to review by Competent Authorities and Notified Bodies. Beyond meeting regulatory demands, a well-prepared TD also facilitates future updates, supports product variations, and enhances overall efficiency in managing your product portfolio. Navigating the complex regulatory requirements that shape the structure and content of your product TD demands cross-functional expertise.
Our cross-functional team of quality, regulatory, clinical, and medical writing experts provides the comprehensive knowledge and actionable support needed to develop compliant, concise, and thorough Technical Documentation for your medical device or IVD, ensuring successful assessment by the relevant reviewing bodies.
