Medical Devices

In assisting you, Alfa Omega aims at offering a tailored service based on your specific needs and compliant with the new EU Regulation 2017/745 of April 5th, 2017, implemented on May 25th, 2017, which will have to be applied by those concerned by May 25th, 2020.

Our team can assist you with:

  • Realizing your product
  • Placing the product on the market whilst complying with any legal obligation
  • Identification and traceability of the devices in European databases
  • Medical devices classification and compliance evaluation
  • Drafting data sheets and risk assessment to set up/ review/ update product technical files in order to obtain/ retain/ renew the CE marking
  • Technical documentation and risk assessment
  • Declaration of conformity
  • Clinical investigation and evaluation
  • Direct contact with the Notified Bodies and assistance in order to obtain/retain the CE marking
  • Manufacturer registration and direct notification to the Ministry of Health
  • Consultancy concerning regulatory protocols for import and export operations and applications for Certificates of Free Sale (CFS)
  • Vaginal suppositories
  • Rectal suppositories
  • Vaginal douches
  • Internal/ external use creams
  • Single dose vials
  • Mouth/ nose sprays
  • Oral solutions
  • Blister packaging
  • Vial packaging
  • Single dose strip packaging
  • Single dose vial packaging
  • Folding carton packaging
  • Labelling
  • Sleeve packaging
  • Thermoformed packaging
  • Physicochemical Testing
  • Microbiological testing

Are you interested in this service?

Contact us for more information!