Maintenance

Knowing what is required

Only someone who is familiar with the currently valid standards and legal requirements can give your device the best possible representation. We take over the maintenance of the technical documentation and conformity check for your products, ensuring that you are never behind with the paperwork.

What we can do for you

• We provide you with external assistance in the performance of internal audits and supplier audits in accordance with DIN EN ISO 9001, DIN EN ISO 13485, DIN EN ISO 19011.
• We prepare you for the FDA with a mock inspection (QSR, QSIT).
• We assist you with the drafting of supplier agreements and OEM contracts.
• We conduct literature research on your behalf as part of the post-market clinical follow-up and market observation, and keep you informed of developments.
• We study the latest standards and regulatory requirements and make sure you are fit to face competition.
• On request, we will also maintain the product documentation for your articles.