Your way to a certified QMS according to ISO 13485
Are you a supplier and currently certified to DIN EN ISO 9001:2015-11,
but want to meet ISO 13485
requirements in the future to remain competitive? We can help you uncover the gaps between the requirements of ISO 9001 and ISO 13485. To do this, our experts perform a GAP analysis on your documents and present the results to you. If required, we can also make the necessary adjustments for you or create the necessary documents to meet the requirements of ISO 13485.
You are a medical device manufacturer and would like to have your QM system certified according to ISO 13485? We will gladly support you in finding a suitable certification or notified body.
After you have found a certification or notified body, we will carry out the complete required management assessment according to DIN EN ISO 13485
, chapter 5.6 and internal audits according to chapter 8.2.4 with you. With the preparation of the required documents and the execution of the management assessment and the internal audits, you are well prepared for the certification. We are also happy to accompany you through the certification process.
We are also happy to accompany you through the external certification process - as a link between the certification body or notified body and the manufacturer. We prepare you optimally start from the application stage onwards, so that no additional effort is required of you and the certification process runs smoothly.