Quality First International

Quality First International is a leading, global medical devices consultancy, with extensive insight and business know-how in the medical devices regulatory field. QFI is committed to solving your regulatory, technical and compliance challenges to enable your medical device to enter the global marketplace.

With our technical expertise, accuracy and confidentiality we can help you be the first to market, reinforce the approval of your medical device, resolve any compliance issues and solve other problems encountered during the regulatory approval of your medical device.

QFI has created a critical mass of insight expertise and business knowledge in all regulatory related disciplines. This allows us to focus our services on six core capabilities:
– International regulatory and compliance issues concerning medical devices
– National regulatory and compliance issues concerning medical devices
– Development and scientific support
– Microbiology
– Quality Management Systems
– EU Authorised Representation
– Medical device registration
– Clinical trials

We have extensive experience in the following technologies:
– drug-device combinations
– cardiovascular and minimally invasive devices
– implants
– TSE and animal-derived medical devices
– personal protective equipment
– clinical monitors
– silver-based products

QFI works in the international domain, with particular emphasis on the European Union and North America. QFI medical device consultancy works with clients in five continents ranging in size from start-up to multi-national companies, from small, discrete projects to full Quality Management System implementation and technical support including preparation of submissions. No matter what your requirements, QFI has the appropriate experience to assist you.

Company’s Keywords:

medical devices