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Quality & Standards

Quality Standards

As a regulated manufacturing facility, Bhi is fully in compliance with ISO 13485:2016.

Our facility is inspected regularly to ensure we are in compliance with the requirements set forth by ISO 13485 & CFR 820(QMS) Standards.

All of our dental implants received the FDA 510(k) clearance, No. K103280.

Quality Policy

BHI management is applying a Quality Management System according to EN ISO 13485 Standard. As such we have acquired the commitment of assigning both the necessary human resources and technical resources for the development and progress of our activity, developing and producing dental implant devices, abutments and their accessories.

Our Quality Policy is focused on the optimal service level to our customers, which includes:

1. Patient Safety

2. Regulatory Compliance

3. Customer Satisfaction

4. Product Performances and Effectiveness

5. Maintain an Effective Quality System

6. Always Improving

It is the policy of BHI Implants to provide high quality products and services that consistently meet the needs and expectations of our customers and the regulatory requirements of the medical devices' industry.

Our objective is to demonstrate top level of both technology and quality, utilizing state-of-the-art methods. In order to implement our quality policy and fulfill our goals, BHI Implants management is committed to:

* Fulfill or exceed Customer needs and expectations by delivering a quality product in a consistent and timely manner.

* Continuously challenging ourselves to improve the quality management system to guarantee product safety, prevent quality incidents and eliminate defects through annual review of quality objectives and results.

* Promote a working environment where training and tools are provided for all employees and their roles in order to proceed in a safe and efficient manner.

* Encourage employees’ comprehension and involvement in BHI's quality goals and quality policy.

* Put the necessary resources of training employees in all organization layers, assuring high skills and competence of the human resource.

* Provide a system of policies which are periodically reviewed to ensure the ability of all personnel to perform their work adequately, effectively and with high level of responsibility and awareness to implications of irregularities.

* Maintain an Effective Quality system by planned audits, management reviews and customer satisfaction surveys.

* Discover ways to expand BHI Implants technology into different fields or applications.

Our management systems, practices, products, suppliers and employees must be measured in terms of performance. To ensure that customer Safety and satisfaction is achieved at all times.

All our employees in our organization are committed to this Quality Policy.

The content of the Quality Policy regarding its suitability and effectiveness is reviewed annually.

Asaf Feuerstein