Regulatory Affairs

We ensure regulatory compliance

We offer our customers comprehensive support in conformity assessment, approval and maintenance of certification of your medical devices.

Product certification in the medical device field requires extensive expertise and compliance with strict regulatory requirements. At AcesoMed, we offer tailored regulatory consulting services that range from identifying all relevant regulations to the successful approval of your medical devices. Under close supervision from our experts, we partner with you to ensure that your products reach the market safely and in compliance with the law – be it CE Mark approval and Medical Device Regulation (MDR) for the European market or FDA approval for the US market. With deep expertise and an in-depth understanding of regulatory requirements, we provide the support you need to turn your visions into innovative medical solutions.
Regulatory Affairs

Our regulatory affairs service packages

Product certification and conformity assessment

Successfully mastering the path to CE marking
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.

Regulatory compliance

Meeting normative and regulatory requirements
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.

Implementation of the Medical Device Regulation (MDR)

Achieving MDR compliance with our expertise
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.

Implementation of FDA requirements

The path of your products to the US market
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.

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