Our services
We use our broad knowledge and more than 25 years of experience to navigate our clients from the early design and development till device distribution and post-market surveillance activities, with the main focus on the EU and US markets.
Our customers are small start-up companies, as well as large established manufacturers and distributors.
Our approach is always practical, while we are consistently focused on patient safety, effective quality management system, fastest path to the market, and the right balance between the customers‘ commercial needs and the applicable regulatory requirements.
If you want to comply with the latest device regulatory requirements or implement a lean quality management system for your device, just contact us. We will analyze your needs and provide you with an effective quotation for your project.
Regulatory strategy
Considering regulatory requirements is very important for any company who intends to design, develop and sell a medical device.
EU CE marking
In order to place a device on the market in EU, a manufacturer needs to obtain a CE mark for its medical device. CE marking is the evidence that a device complies with the EU regulations. It is currently required in more than 30 European countries.
US FDA clearance and approval
The US is the world’s largest medical device market. Medical devices marketed in the United States are subject to the regulatory controls by the U.S. Food and Drug Administration (FDA). With the focus on EU manufacturers who intend to sell in US, Meliora Compliance will help you to obtain the regulatory approval/clearance for your device in US.
Quality management system
To implement and maintain a quality management system (QMS) is an essential condition of regulatory compliance for the entry to the majority of world markets.
Regulatory partner for desing and development
There is long way for a device to reach the regulatory approval. However, already in the early pre-market phase, the design and development activities must comply with applicable regulatory requirements from the very beginning.
Regulatory partner for clinical study
Clinical studies and post-market clinical follow-up activities are essential for market entrance, as well as for the long-term maintenance of your medical device regulatory approval.
Auditing
Audits and inspections are essential for all medical device manufacturers and other economic operators.
Training
Regulatory requirements have been constantly changing. Medical device industry professionals must be able to understand and properly implement the requirements so that compliance is maintained.
Meet us
Jan Kloboucnik is the founder and the principal consultant of Meliora Compliance. He has been in the medical device industry since 1996.
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