Challenges

There are several challenges companies face with respect to quality management representatives: 

• The business is just too small to justify staffing a quality management representative and the education is too expensive to provide. Even though the QM representative is required by ISO 13485, section 5.2.2...
• You have a quality management representative, but who listens to the prophet in his own country?
• You did the internal audits so many times that you start losing touch with your own work. You want an external,unbiased view on your quality management system. 

We serve you as external QM representative

You do not have to do everything yourself: We will gladly support you as an external QM representative. Thereby you benefit in several ways:

• You are always fully prepared for upcoming audits. You won't have to deal with late rushes, because we support you continuously. This way, you remain ISO 13485 compliant permanently.
• You know not only just the weak points, but you have concrete and easy-to-implement ideas for improvement. You cannot have both these words together. They mean the same thing. Choose one only.
• You are always up-to-date with the latest trends and regulatory changes.
• You have a designated contact whom you know well and who knows you well. This saves a lot of time and misunderstandings.