Regulatory Affairs

CE marking is the central step in the marketing of medical devices in Europe. Our regulatory affairs experts guide you through the entire compliance process until your medical devices are successfully CE marked. We ensure that your products meet all regulatory requirements to ensure smooth access to European markets. From the initial assessment of your product compliance to the final submission of the required documentation, we stand by your side as partners. Our goal is to guide you through every step of the certification process efficiently and in compliance with the law, so you can focus on what matters most: developing innovative medical solutions that sustainably improve patients’ lives.

In the complex field of regulatory compliance, adherence to relevant regulations and standards is critical for the development, manufacturing, and marketing of medical devices. AcesoMed offers comprehensive support to minimize compliance risks and ensure that you operate in a legally compliant manner. Our experts carefully analyze the relevant requirements placed on your medical device and guide you through the entire approval process: from identifying the standards relevant to your medical device to continuous compliance with regulatory requirements, we are there to assist you closely. With our support, you can be confident that your medical devices meet the highest quality standards and satisfy the requirements of global markets.

The smooth implementation of the requirements of the Medical Device Regulation (MDR) poses major challenges for the entire medical technology world. It has a decisive influence on the approval and placing on the market of medical devices in the European Union. With our experience, we support our customers in successfully managing the transition from the MDD to the MDR and in developing entirely new products in compliance with the MDR. Our team of experts knows the requirements of the MDR in detail and supports you in adapting your quality management system, in updating your technical documentation and in all further steps required to successfully bring your products to market in accordance with the MDR requirements. Together, we achieve the goal of meeting the strict requirements of the MDR and being able to distribute your medical devices in the EU in a legally compliant manner and without delay.

As a medical device manufacturer, you face the specific requirements of the FDA (Food and Drug Adminstration) when it comes to launching your products on the US market. While there are some similarities between these FDA requirements and the MDR requirements, some important differences make thorough preparation as well as a deep understanding of the regulatory landscape in the US necessary. Our experts support you in the successful implementation of FDA requirements for the approval of your medical devices on the US market. We support you not only in compiling the required documentation, but also in analyzing and adapting your products to meet the high US standards. Our goal is to pave the way for you to enter the U.S. market while ensuring that your medical devices meet the highest quality and safety requirements.