Worldwide expertise

Quality & Regulatory Affairs

Global and extensive experience in Regulatory Affairs worldwide.

Our dedicated teams apply the experience and accumulated knowledge about medical device regulatory system in different countries, ISO standards for medical devices, regulatory requirements, and documentation for application.

Make your product available in the market of your interest

We can help you in the registration process in every market.

Regulatory Affairs

Worldwide expertise in registration

Global presence is a key issue for Leventon. This has made us know the requirements of each market and we have achieved a wide experience in different markets.

We own many Registrations and Certifications in Europe (CE mark), in the USA (FDA), MDSAP (US, Japan, Australia, Brazil, Canada) as well as other countries. MDR in progress.

Different agencies (Notified Bodies, FDA, WHO, ANVISA, and CFDA among others) have certified our products and processes.

Our Market Surveillance team carries out the activities of Complaints, Field actions, and Vigilance system.

Highest quality assurance standards

Broad expertise worldwide

As a manufacturer of Medical Devices, Leventon has a Quality Policy that is aimed at fully meeting the expectations of customers (distributors and, through them, hospitals centers, health personnel and patients) as regards the Quality and Service of its products, as well as all legal and regulatory requirements of the sector.

Highest quality assurance standards:

  • Certified QMS ISO 13485:2016 (UL UNDERWRITER LABORATORIES INC)
  • CE Mark 2017/745 (MDR) EU Medical Device Regulation (DQS)
  • FDA Registered establishment since 1985.
  • MDSAP Certification - Medical Device Single Audit Program
  • Many other Registrations and Certifications (China, India...)