Medical devices consultancy
At Supplaffairs we stand out for providing services of review and adaptation of labeling, instructions for use and advertising material for your medical devices. In addition, we manage the advertising authorization and we process the distribution and manufacturing and/or import license.
Our team is in charge of notifying your products to the AEMPS to comply with regulatory requirements.
We also offer advice and support in the drafting of Standard Operating Procedures and technical contracts.
At Supplaffairs, we ensure the quality of your production and storage facilities, providing support for internal audits, supplier audits, certification or inspection. Rely on our tailor-made training and third-party technician services to comply with current medical device regulations and be prepared for the demands of new European regulations.
Services we offer
- Review and adaptation of labeling, instructions for use, advertising materials and web content, blogs or social networks
- Application for advertising authorization
- Application for Registration of Distribution of Medical Devices
- Application for a License to Manufacture and/or Import of Medical Devices
- Notification of products to the AEMPS through CCPS (Communications of Medical Devices)
- Application for National Parapharmacy Code
- Revision and drafting of Standard Operating Procedures (SOP's)
- Review and drafting of technical contracts
- Overhaul and adequacy of production and storage facilities
- Support for internal audits, supplier audits, certification audits or inspection audits
- Tailor-made training
- Third-party technical manager
