We help medical device manufacturers and start-ups 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 and quality management systems such as; 
✅EU MDR 2017/745
✅EU MDR 2017/746
✅US FDA 510 (K) Submission
✅ ISO 13485 including MDSAP scheme 
✅ISO 14971 Risk Management
With the latest revisions, the medical device regulations such as MDR, IVDR have been more complex than ever for medical device start-ups. 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.
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. Our team with Notified Body experience is competent in risk management technical, regulatory, quality, and clinical requirements will provide you tailored solutions. 
This approach will speed up your certification process, 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.
Do not hesitate to contact us via askto@medloft.net or through https://medloft.net/contact-us/ 
We will analyse your needs and provide an effective, fast and reliable roadmap.

Medloft Consultancy Doo

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