Medical devices
WE ACCOMPANY YOUIn adapting to new regulations
WE PREPARE THE DOCUMENTATION YOU NEEDFor medical device procedures
WE HELP YOU TO MANUFACTURE YOUR PRODUCTWe select manufacturing/packaging centres and assist with product imports
WE COLLABORATE WITH YOU THROUGHOUT YOUR PRODUCT'S LIFE CYCLEWe manage your product's safety and efficacy trials
At C&U ASSESSORS we accompany you throughout the phases of your project:
from design to manufacturing and introduction to the market, implementing essential safety and quality requirements along the way
OUR EXPERT SERVICES FOR MEDICAL DEVICES
- Advice and assistance in adapting to new medical device regulations. Definition of methodological, ethical and clinical elements to govern medical device clinical research. Search for Regulatory Compliance Manager. (“Regulatory compliance”). Adaptation to Unique Device Identification system (UDI).
- Management of Spanish licence for medical device facilities for businesses in Spain that carry out manufacturing or importation activities and submission of paperwork to the Spanish Agency for Medicine and Medical Devices.
- Inspection of premises (your own and/or subcontracted ones) to check they comply with current regulations.
- Search for Technical Manager and subcontractors.
- Advice on safety and efficacy trials. Advice and assistance on biocompatibility testing, packaging materials testing, material and product compatibility, disinfectant efficacy testing, formula bactericidal/bacteriostatic activity, etc.
- Search for laboratories to carry out safety and efficacy trials. Follow-up. Establishment of protocols.
- Management of CE marking: Compliance declarations and CE certificates.
- Notifications needed to introduce products onto the market.
- Checks on labelling, information leaflets and documentation to comply with legal requirements. Management of medical device licensing in accordance with Spanish laws RD 1591/2009 and RD 1662/2000.
- Application for National Codes for distribution to pharmaceutical distributors and pharmacies (voluntary).
- Technical file for medical devices, in accordance with current legislation.
- Application for Certificates of Free Sale for exports.
- Dossiers to register your products and export them overseas. Labelling.