Quality

Reliability is important for Us

Our company aims to manufacure innovative products of premium quality, which are beyond customers’s expectations and comply regulatory requirements.

Our basic principles during ensuring the quality of our activities:

• Customer needs fulfilment at a high level.
• Ensuring full compliance with legislative requirements.
• Increasing the product offer while constantly taking into account customer needs.
• Establishing reliable partnerships and subcontractor relations.
• Continuous development, innovation.
• Environmental awareness.

The quality of the products is guaranteed by design, manufacturing and quality management according to the harmonized European Union laws. The BIONIKA Medline Kft. is operated according to the MSZ EN ISO 9001 and the MSZ EN ISO 13485 quality management system. Our products are provided with CE marks, which is ensured by NEOEMKI. We provide a long-term guarantee for our products. After inserting the implant, reducing the medical risk of the ossification process, independently of cause and effect relationship – exchange guarantee is ensured within one year after the purchase for the dropped and fallen out implants.

 

MSZ EN ISO 9001:2015	MS EN ISO 13485:2016
CE Certificate	CE Certificate attachment

 

BIONIKA Medline Kft. has always paid close attention to quality and reliability during its nearly 30 years of existence. The Bisnode certificate is a proof of our reliability and stability.

At the Hungarian market only 0.63% of the companies have the AAA Bisnode rating. The financial risk of establishing business relationship with these business associations is extremely low – source: https://www.bisnode.hu/szolgaltatasok/bisnode-tanusitvany/