Our Services

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Regulatory Affairs

You have successfully obtained the market clearances of your products.
You are wanting to expand you product line and adapt them to new markets.

We can assist you in :

Technical development of new products or new product line

• Defining the regulatory requirements of new products
• Assessing the need to pass through new certification phases
• Updating technical files
• Preparing certification audits

Regulatory Affairs:

• Realizing the regulatory surveillance
• Maintaining mandatory technical files (CE mark) and DHF, DMR (FDA)
• Renewing the certification audits and homologations
• Managing the regulatory affairs in new markets

Most of junior companies obtain market clearances on the first try for their first products.
Things can get worse with next products as companies have to dedicate resources to commercial efforts to get expected revenue.

We can help you in this critical phase where design and regulatory constraints shouldn't be put aside.

Contact MD101