Meliora Compliance
Regulatory and QMS consulting
The mission of Meliora Compliance is to provide regulatory and quality management system support to medical device designers, manufacturers and other economic operators throughout the entire product life cycle.
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.
Founder and Principal Consultant
Jan Kloboucnik
Jan Kloboucnik is the founder and the principal consultant of Meliora Compliance. He has been in the medical device industry since 1996.
Prior to Meliora Compliance, Jan worked in various quality system/control/assurance and regulatory affairs positions in small and large medical device developing and manufacturing companies: Arrow International/Teleflex, Contract Medical International and Heraeus Medical Components. Jan has a long history of working with development, manufacturing and clinical study teams, distributors, inventors, EU certification and notified bodies, competent authorities and US FDA on a broad range of product technologies and indications in the following product fields: cardiovascular, endovascular, oncology, electrophysiology, endoscopy, neurosurgery, gastrointestinal, respiratory, urology and cosmetic surgery. Jan has led regulatory teams whose work resulted in receiving numerous approvals and clearances in EU, US and ROW, and thus enabled successful launch of many devices worldwide, including novel and highly innovative products.
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