C-REG Medical's mission statement

• Help small to medium-sized manufacturers/distributors of medical or in-vitro devices
• Provide comprehensive advice and personalised accompaniment to achieve compliance with European, American and other foreign regulations
• Enable companies to sell their devices and products on foreign markets

What can C-REG Medical do for you ?

• Help you acquire an efficient understanding of the international standards, European directives and American regulations which apply to you
• Facilitate discussions and interface with regulatory institutions (e.g. the FDA, ANSM, etc)
• Help you set up a global and efficient strategy to reduce the time to market 
• Enhance understanding and allow integration of regulatory obligations within your company

Anticipate...
Think "regulatory compliance" whilst developing a new device !

Whatever the size of the company, regulations apply equally... 

As regulations cannot be avoided, regulatory education and knowledge must be integrated across your organisation.
Omitting to think about foreign regulations while developing a new device may lead to damaging consequences : a faulty design, lengthy time to market or even impossibility to enter foreign markets.

Where should you start ?

C-REG Medical can help to identify your needs by carrying out an audit of your company with respect to the regulatory obligations and standards which apply to you.

Whatever your needs, C-REG Medical helps you assess and establish your requirements, timelines and budget.

My approach : talk first, then we'll work together !