Outstanding work
KH AND KH MEDICAL PURSUE ONE GOAL
As a goal, we pursue a zero-error quota. The determination of the company’s policy secures the expectations and demands of our customers. Our top priority is customer satisfaction. Our company observes existing laws and regulations as well as regulations arising from approvals. We consider it our task to take sustainability, energy efficiency as well as cost effectivity into consideration when acquiring raw materials, products and services. We consider it our responsibility to nature and the environment. Investments are made based on a sustainable and healthy development of the company. It is our aim to remain independent, ever-expanding and therefore flexible.
Ready for MDR – KH is in!
EVEN MORE SAFETY FOR MEDICAL PRODUCTS
Since May 2021, the MDR (Medical Device Regulation, EU 2017/745) has regulated the requirements for medical products in the European Union and improved their quality and safety. In combination with the EN ISO 13485:2016, the MDR implicates an «end-to-end» monitoring of the entire value-added chain, including the subcontractor. As a partner of high-profile customers, KH Medical has established the necessary conditions required to fulfil all aspects of the MDR. It is our pleasure to support you with you products.
OUR STANDARDS
- Clean room ISO 14644-1 Class 8 with bio-monitoring, more on request
- DIN ISO 9001 and EN ISO 13485 certified
- Risk assessment and process FMEAs
- Requalification of devices/facilities
- IT system validation
- Risk-based supply management according to 2013/473/EU
- End-to-end monitoring of critical (sub) contractors
Together with you, KH Medical sets new standards in the healthcare industry.
