The Medical Device Regulation (MDR) has tightened the regulatory requirements for many established and safe products. Together with you we will find the right strategy for conformity assessment. We support you in assessing for which medical devices of classes I-III in your portfolio the changeover is worthwhile and whether the effort can be reduced, for example, through permissible literature references. For borderline products, we advise on questions of demarcation and identify attractive alternatives, but also suitable portfolio additions for our customers.

 

Market access and product maintenance with responsibility

The success and safety of your medical devices are in the best hands with TentaConsult. We create and maintain the necessary documents, documentation and QM systems. In short: We support you in all tasks and decisions up to market access – and also take personal responsibility beyond that.

 

On behalf we take responsibility:

• Conformity assessment procedure
• Clinical Evaluation Report (CER)
• Risk management
• Biological Evaluation Plan (BEP) / Report (BER)
• Establishment of QM systems (ISO 13485)
• Tests for biocompatibility / biological safety

 

We take over responsible roles:

• Safety Officer (acc. to § 30 MPG)
• Person Responsible for Regulatory Compliance (PRRC) (acc.to Art. 15 MDR)