SAVE PRECIOUS TIME AND AVOID REWORK ON REGULATORY SUBMISSIONS
Each market has its own technical file requirements. While guidance usually exists, it can take time to understand and interpret the requirements, especially when they are in another language.
Our experts provide consultation and support for the preparation and evaluation of technical documentation and design dossier of your medical devices according to the appropriate guidelines for submission to European notified bodies and to non-European regulatory authorities.
Whether you need us to become the regulatory arm of your company or if you need someone to spot check your work, we will hold your hand throughout the process as an extended part of your team.
We’ve found manufacturers needs are unique and have provided these services and more for other clients:
For “borderline products” in the demarcation between medicinal products, cosmetics and medical devices we prepare expert reports on the classification in compliance with MDD 93/42/EEC and MEDDEV 2.4/1 Rev. 9 respectively MEDDEV 2.1/3 Rev. 3. If necessary, we will justify the proposed classification towards your notified body or competent authority.
Keep up to date with UL Solutions by signing up for your newsletter:
You have successfully signed up for our newsletter. You should receive a confirmation email shortly.