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.
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
- Single dose strip packaging
- Single dose vial packaging
- Folding carton packaging
- Labelling
- Sleeve packaging
- Thermoformed packaging
- Physicochemical Testing
- Microbiological testing
