quality statement

The company, advanced fiber tools GmbH, Mittweida, Germany, has a procedure and process-oriented quality management system according to EN ISO 13485 and a quality assurance system according to EC Directive 93/42 / EEC, Appendix V.

The medical devices manufactured and supplied by advanced fiber tools GmbH are subject to the strictest quality assurance criteria.

The medical devices manufactured and supplied by advanced fiber tools GmbH meet the requirements of the DIN EN ISO 10993 ff. in terms of their biocompatibility, depending on the respective purpose.

On customer request, our products can be delivered in a sterile condition. A partner company guarantees a validated ethylene oxide (EtO) sterilisation process according to DIN EN ISO 11135.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THE FOLLOWING ARE AVAILABLE FOR OUR DEVICES:

  • Sterility certificate according to EN 556-1
  • Proof of absence of bacterial endotoxins (LAL-Test according to EP-BE: pH. Eur. 5 Chapter 2.6.14)
  • EtO residual gas analysis according to DIN EN ISO 10993-7
  • Bioburden determination according to EP-ME: pH. Eur. 5 Chapter 2.6.12
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The materials used in the production of our medical devices meet, for example, the requirements of USP Class VI, DIN EN ISO 10993-1, DIN EN ISO 10993-5 or ASTM. No latex-containing materials are used. All materials used to package our medical devices meet the requirements of DIN EN ISO 11607 and DIN EN 868.

We realise reproducible environmental conditions in the manufacture (clean room class D according to EU Guide GMP, Appendix 1, 100,000 according to US Federal Standard 209 E, and ISO Class 8 or DIN EN ISO 14644-1). Clean room monitoring is regularly performed at our premises by the national licensing office (ZLG in Germany) accredited laboratories.

As part of our production process, we utilize validated processes for the execution of adhesive bonds and calibrated measuring, e.g., and for test equipment for devices and processes.

STATUTORY AND REGULATORY REQUIREMENTS

Compliance of our devices with legal regulations and specifications, as well as with normative requirements related to the manufacture and distribution of medical devices, is a responsibility that the company, advanced fiber tools GmbH, takes as a matter of course. According to the Guidelines for the Classification of Medical Devices (Annex IX of Directive 93/42 EEC), these are class IIa medical devices (ophthalmic and surgical laser probes) that are used intermittently and are surgically invasive.  
As part of the introduction of the quality management system, reference is made in the technical documentation to requirements or standards and laws that apply to advanced fiber tools.

The inclusion of the medical device-related relevant aspects and regulations of the current standard DIN EN ISO 13485 takes place through practical involvement as we carry out our activities.  

The coordination of the legal and normative requirements for the production and distribution of the medical devices and associated processes and activities is incumbent on the Medical Device Consultant in collaboration with the Medical Device Safety Officer.

Customer orientation

Top management is committed to identifying and meeting the customer’s requirements and the regulatory requirements.  
Determining our customers’ satisfaction with the execution quality of our devices and services is a key criterion for advanced fiber tools GmbH in fulfilling and implementing our quality policy and quality objectives. For this reason, the Medical Device Consultant regularly conducts surveys to obtain relevant vigilance data and feedback from our customers as to the safety, quality, and applicability of our performance. Included here are exclusively the methods and procedures from the VA_7_10 "Vigilance System," in which the market observation of our medical devices is regulated.

Quality policy

The company, advanced fiber tools GmbH, has risen to the market challenge of achieving high quality standards for our devices and associated services. To attain this, the quality policy has been declared a top priority, and the following principle has been placed at the centre of our business policy:

We strive to be among the most customer-friendly companies in the industry.


For our company this means:

  • We meet the needs of our customers by delivering safe, reliable and user-friendly devices.
    The benchmark for the quality of our medical devices is determined by advanced fiber tools in cooperation with the customer. The customer’s judgement is the decisive factor.
  • Customers are supplied only with faultless devices.
    We aim to avoid mistakes from the outset rather than correct them afterwards.
  • Through our conduct and our daily performance, we aim to gain and maintain trust and recognition among our business partners.
  • Advanced fiber tools GmbH products are characterised by a very high level of technical know-how.  
    We give priority to close contact with our suppliers and customers along the entire value chain in order to make the performance of our medical devices effective for the user.
  • Our company's philosophy utilizes close customer contact to enable rapid incorporation of new experiences and insights into our medical devices and processes.
  • The company’s employee training program forms the basis for our ability to implement the rapidly changing technical and technological requirements to our customers’ satisfaction.
  • Our quality management system is continuously improved and reviewed through regular management reviews and internal system audits. Any resulting changes will be immediately assimilated.
  • As a manufacturer of medical devices, we are aware of our responsibility for patient safety. We therefore routinely subject the processes involved in the manufacture, distribution, and use of our medical devices to risk management considerations and assessments.

All these demands set the standard for the continuous improvement of our business processes.

Environmental protection

Environmental protection plays a key role in the manufacture of our devices.  
Appropriate employees of the company are regularly trained in the handling of substances and instructed in professional separation and storage. Any accumulated waste, used materials, and environmentally relevant substances are disposed of in accordance with the requirements of the Recycling and Waste Management Act.