Helmut Zepf Medizintechnik GmbH maintains a certified quality management system in accordance with DIN EN ISO 13485:2021 – EN ISO 13485:20216 + AC:2018 + A11:2021 – ISO 13485:2016. Our risk management is based on ISO 14971 with application of the Medical Devices Act (MPG).

We also include international guidelines in our quality management program, such as those of the US Food and Drug Administration (FDA).

Being the “best” you can be every day is what management demands of itself and of its employees.

Our customers are entitled to a functioning instrument, which is our sole raison d’être as a manufacturer of medical products.

Should something go astray, we take care of it – quickly, professionally and in a customer-oriented way.

That’s a promise!