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Regulatory Strategy

You have designed a product and used it on field for clinical research purposes or in simulated clinical environment.
You are wanting to obtain the clearances to place your product on the market for real clinical use. 

We help you pass through the mandatory phases to obtain market clearance in the US or in Europe : 

Building your ISO 13485 Quality Management System :

• Creating quality manual, procedures and forms
• Training your personnel
• Validating processes
• Validating software
• Acting as quality manager for your company
• Passing the ISO 13485 certifications audits

Helping your company for CE Mark :

• Adapting your Quality Management System (QMS) to CE mark
• Adding instructions to comply with requirements of national authorities, complementary to CE Mark

Adapting your Quality Management System to 21.CFR requirements Creating the mandatory technical files

• Technical file for CE Mark
• 510(k), DMR and DHF for FDA

Improve your technology design and ergonomy based on KOLs surveys in priority markets for mass market commercialization.

You can rely on our expertise for new technology (medical devices, software) registration (CE, FDA) and certification (ISO 13485) to accelerate the process to market clearance of your products.

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