External PRRC

Qualified experts, a customized solution

The regulations allow small companies (within the meaning of Recommendation 2003/361/EC) to outsource the function of the Person Responsible for Regulatory Compliance (PRRC).
If you are a medical device manufacturer, MD101 can provide you with a person who has the skills and experience required to carry out the necessary checks and monitoring:

• The permanent availability of the PRRC by assigning you a team of three people (one permanent and two substitutes).
• Obligations concerning clinical investigations are fulfilled.
• Obligations concerning vigilance notifications are fulfilled.
• Technical documentation and EU declaration of conformity are established and kept upto-date.
• Device compliance is ensured.
• Post-marketing surveillance obligations are met.