About Us

With 20+ years’ experience, we are constantly working for better service. Our mission is to help legal manufacturers to improve safety of medical devices. We work continuously with them throughout the complete product life cycle. Our main focus is design assurance and compliance with the applicable regulations. To help our customers in this complicated journey, we use our wide knowledge and experience to simplify the process. By doing this we always consider the balance between commercial needs and regulatory compliance.

With the latest revisions, the medical device regulations have been more complex than ever. All regulators within the developed countries are trying to increase the safety of medical devices within their market. Therefore, patient safety and compliance to regulatory requirements constitute the basis of our consultancy project objectives. Our customer-focused team provides effective and fast services for each type of project and medical device.

MEDLOFT has a strong international team having Notified Body experience. Our staff, with technical, regulatory quality and clinical competence will provide you tailored solutions, whether you are a small start-up company or a competent medical devices manufacturer which aims to put new devices on the medical device market.

In short, MEDLOFT provides regulatory and quality solutions that accelerate the success of medical device companies to bring their products on the market.

If you want to comply with the revised regulations, have an effective quality management system for your product realization processes or to have your design reviewed for specific technical standards just contact our expert team. We will analyse your needs and provide you an effective quotation for your project.