I will provide iso 13485, ce, eudamed, mdr, eurep, srn

I know it's tough to make all the necessary paperwork and get those certificates. But guess what? It's super important if you want to sell medical devices in Europe! ISO 13485:2016 is like a rulebook that tells companies how to make sure their medical devices are top-notch. It says that companies have to show that they can make devices and provide services that always meet what the customers want and what the rules say. So, it's like a big thumbs up for quality!

A European Authorized Representative (EC Rep) provides a point of contact between you (the non-European medical device manufacturer) and the National Competent Authorities (Ministry of Health).

• ISO 27001 information security management system
• Quality Management Manual
• Quality procedures (Document Control, Purchasing, Audits...)
• Quality Forms (Training Matrix, Management Review, Quotation..