Hair Transplant Instruments Quality
Scharf Surgical Instruments®
Introducing Scharf FUE Instruments: Revolutionizing Hair Transplantation
Scharf FUE Instruments are at the forefront of innovation in the field of hair transplantation. Designed with precision and crafted to the highest standards, these instruments are revolutionizing the way hair restoration procedures are performed. With years of expertise in the industry, Scharf has developed a comprehensive range of FUE instruments that meet the specific needs of surgeons and ensure optimal patient outcomes.
Our FUE instruments feature advanced technologies and ergonomic designs, providing surgeons with the precision and control necessary for seamless extraction and transplantation of individual hair follicles. From specialized punches that minimize trauma and maximize graft viability to delicate forceps and implanters for precise placement, Scharf FUE Instruments offer the perfect blend of reliability, efficiency, and patient comfort.
At Scharf, we understand that each patient is unique, and their hair restoration journey requires personalized solutions. That’s why our FUE instrument range includes a variety of sizes and configurations, allowing surgeons to tailor their approach according to patient characteristics and preferences. Our commitment to continuous improvement ensures that our instruments remain at the cutting edge of the industry, incorporating the latest advancements in technology and surgical techniques.
When it comes to hair transplantation, precision and results matter. Scharf FUE Instruments empower surgeons with the tools they need to achieve exceptional outcomes and transform the lives of their patients. Experience the difference of Scharf’s unrivaled quality and performance – the choice of leading hair restoration professionals worldwide.
Hair Transplant Instruments Quality Management
Quality Policy: “Scharf FUE Instruments ® is committed to providing our customers with the highest quality products at an exceptional value. We strive for total customer and patient satisfaction by continuously improving our products, processes and Quality Management System”
FDA Approved,
The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
ISO 13485:2004
ISO 13485:2004 specifies requirements for a Plastic Surgery Instruments Quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 18001:2007 ;
OHSAS 18001:2007 is an internationally recognized assessment specification for occupational health and safety management systems. OSHAS provides a framework that allows the organization to consistently identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance
ISO 14001:2004 ;
ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence.
ISO 9001:2008 ;
Scharf FUE instruments has implemented a quality management system, which has been certified ISO 9001:2008. It specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements andaims to enhance customer satisfaction through the effective application of the system, including processes for continual improvementof the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 17664:2017 ;
ISO 17664:2017 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification.
TSE_HYB ;
Scharf FUE Instruments is certified from Turkish Standards Institution (TSE).
EC Declaration of Conformity. This decleration provides the assurance that products supplied by Scharf Surgical Instruments are in conformity with the essential requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest standards of craftsmanship in accordance with the relevant
