Regulatory Affairs
Regulatory Affairs
The field of regulatory affairs "Regulatory Affairs" deals with everything concerning legal or normative requirements for placing medical devices on the market. From dealing with harmonized standards, to conformity assessment and post-market surveillance, RA experts are the point of contact for the requirements placed on these processes and activities by the relevant regulations for economic operators.
In Europe, these requirements are described in the MDR and IVDR, respectively.
The following pages describe how a device can be put on a wide variety of different markets worldwide. Often, a simple registration or confirmation of approval in the home market is sufficient. However, it can also be complicated; for example in China, the hurdles are particularly high. Additionally, in many African countries, a local contact is essential.
We will help you keep track of the different approval restrictions. Our experts know how to bring your product to market - whether in Europe, Asia or America.
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Regulatory Affairs
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News
Common Criteria for Information Technology Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
Clinical Evaluation for Medical Devices in China
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.
20 years of medical technology approval
We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products