clinical evaluation

Developing a successful clinical evaluation plan (CEP) is a critical step in the process of bringing a Medical Device CE Marking . A well-designed Clinical Evaluation can help demonstrate the safety and efficacy of the device, and ensure regulatory compliance. Here are some key steps to follow when developing a successful CEP for medical devices: Identify the Relevant Regulatory Requirements: The first step in developing a CEP is to identify the regulatory requirements that apply to your device. These requirements will vary depending on the device's classification, intended use, and risk level. It is important to review the relevant regulations carefully and ensure that the CEP addresses all applicable requirements. Define the Clinical Question: The next step is to define the clinical question that the CEP will address. This question should be based on the device's intended use and should focus on the safety and efficacy outcomes that are most relevant to the device. For exam

We are medical device regulatory consultants. We help Medical Device CE Marking companies overcome the complex and stringent regulatory requirements for marketing in the United States. We provide medical device regulatory consulting services. From initial regulatory submissions to US FDA and Health Canada, to CE Marking Approval , 510(k)s, and international equivalents – we have the experience you need.  Our regulatory experts will help you navigate the complex regulatory landscape in order to bring safe products to market faster. Our mission is to deliver the most comprehensive medical device regulatory consulting in the industry combined with leading-edge technology and creative solutions. We are committed to providing value to our clients through advisory services, regulatory education and partnering with clients at every stage of their product life cycle. We know medical devices registration process We know the medical devices registration process, and we know how to help you get

When a company based outside of the United Kingdom (UK) wants to sell its medical device products in the UK, it is required to appoint a UK Responsible Person (UKRP) who will act as a liaison between the manufacturer and the Medicines and Healthcare products Regulatory Agency (MHRA).  Here are some key points to keep in mind regarding MHRA UK Responsible Person Services: What is a UK Responsible Person? A UK Responsible Person (UKRP) is a legal entity appointed by a non-UK manufacturer to act as its representative in the UK. The UKRP is responsible for ensuring that the manufacturer's medical devices comply with UK regulations. What are the responsibilities of a UK Responsible Person? The responsibilities of a UK Responsible Person include registering the manufacturer's medical devices with the MHRA and ensuring that the devices are properly labeled, marketed, and distributed in the UK according to the regulations. The UKRP also serves as a liaison between the MHRA and the ma

A blog about the benefits of obtaining a FDA approval and how you can obtain one. The FDA stands for the Food and Drug Administration, it is an agency of the United States Department of Health that is tasked with protecting and promoting public health. Failing to obtain FDA approval for your product, is illegal. This blog post will explain in detail why you need a FDA approval. FDA Approval is an Assurance If you are a manufacturer or a Medical Device CE Marking , obtaining FDA approval is a must. It ensures that your product meets the standards of quality and safety imposed by the government agency. Furthermore, it provides an assurance to your customers that the product is safe for use. The process of obtaining FDA approval involves several steps which include: Determining if your product meets all the requirements for approval. Providing sufficient data on the safety and efficacy of your medical device. Informing about any risks associated with using your product. FDA Approval

The CE marking is a significant indicator that the product complies with European legislation and allows the free movement of products within the European market. When a manufacturer affixes the CE marking to a product, he declares, under his sole responsibility, compliance with all the legal requirements necessary to affix the Medical Device CE Marking , and thus gives rise to the product being able to be sold in the space European economy, Switzerland and Turkey. This also applies to products made in third countries that are sold in the European Economic Area (EEA), Switzerland and Turkey. The CE marking does not indicate that the product has been manufactured in the EEA, but rather that the product is evaluated before being placed on the market and meets the Union's safety, health and environmental protection requirements.  This means that the manufacturer verifies that the product meets all the essential requirements of the Directives that apply to it or, if stipulated in the D

Due to the increasingly common presence of imported medical devices in the European Union, the figure of the Authorized Representative (EC REP, European Authorized Representative) is becoming more common. This figure must guarantee compliance with current regulations on medical devices for medical devices manufactured outside the European Union.  Regulation 2017/745 of medical devices establishes the obligation for all manufacturers of medical devices established outside the European Union to have a permanent authorized representative who serves as an interlocutor for the European health authorities and has a documentary file with technical information. of medical devices (Technical file among others). The authorized representative must be a natural or legal person based in an EU member state and appear on the labels of Medical Device CE Marking for sale in the EU.  The appointment of this EC REP must be in writing along with its acceptance and in the case of class I products, this ap