We are a company of engineers with over 35 years of consulting experience. Our goal is to implement and manage the entire CE marking process to customers who entrust us with the task on their product. If your product requires it, we follow the whole process of CE certification issued by the Notified Bodies with which we collaborate on a daily basis.In detail the C. &. C. deals with:- CE Marking Advice- Consulting CE Certification (import / export)- Registration of Medical Devices at the Ministry of Health- Drafting of the Technical File- Drafting Use and installation manual- Risk analysis- Declaration of conformity- Implementation of quality systems (ISO 9001, ISO 13485, etc.)- Consulting of new products design (which rules follow, directives, parameters to be respected)- Technical expertise- Pre-Import Consulting (things to do before importing to avoid problems)We can also offer some services to non-European companies.The non-European company that wants to enter the European market must fulfill two obligations:- make products that comply with European directives and standards- have a European entity that can be the importer or an agent who takes responsibility for the CE markingWhile the importer automatically becomes "the legal producer", if the non-European company wants to sell with its own brand it must appoint its representative and can sell throughout the EU.We can do three different and separate things:- 1 check if the products comply with directives and standards- 2 prepare the necessary documentation to comply with European laws- 3 perform the role of authorized representativesIf the non-European producer does not appoint his agent, he has no interest in services 2 and 3, but only in 1, otherwise he can be interested in all three.