quality statement

The advanced fiber tools GmbH operates according to a quality management system certified in accordance with EN ISO 13485. The company manufactures and supplies medical devices that are subject to the strictest quality assurance criteria. All medical devices meet the requirements of DIN EN ISO 10993 ff. with regard to biocompatibility, depending on their intended use. 

Upon customer request, the products are delivered sterile. For this purpose, the company has a partner who guarantees a validated ETO sterilization process according to DIN EN ISO 11135.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THE FOLLOWING ARE AVAILABLE FOR OUR DEVICES:

  • Sterility certification according to EN 556-1
  • Absence certificate of microorganisms on products (Bioburden-Test
    according to DIN EN ISO 11737-1)
  • Absence certificate of bacterial endotoxins (LAL-Test according to
    European Pharmacopeia 10.0)
  • EtO residual gas analysis according to DIN EN ISO 10993-7

Materials used in the manufacture 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. The medical devices we manufacture do not contain any substances subject to special regulations or restrictions, such as CMR substances, phthalates, bisphenols, latex, nanoparticles, or radioactive materials. All materials used for packaging our medical devices meet the requirements of DIN EN ISO 11607 and DIN EN 868.

We guarantee reproducible environmental conditions in our manufacturing process (cleanroom class D according to EU Guide GMP, Annex 1, or 100,000 according to US standard Federal Standard 209 E, or ISO class 8 according to DIN EN ISO 14644-1). Regular cleanroom monitoring and qualification are carried out by a ZLG-accredited testing laboratory. Through qualified facilities, validated processes and calibrated measuring and testing equipment, we guarantee reproducible manufacturing results.

STATUTORY AND REGULATORY REQUIREMENTS

Compliance with legal regulations and standards related to the manufactured and distributed medical devices is a matter of course for advanced fiber tools GmbH when it comes to our product responsibility. According to EU MDR 2017/745, the surgical, ophthalmic, and non-contact laser probes we manufacture are Class IIa medical devices intended for temporary and minimally invasive use. The requirements of EN ISO 13485 are implemented in all activities related to the manufacture of our medical devices. Further requirements from standards and laws are regularly reviewed for relevance and applicability within the framework of our quality management system and implemented as necessary.

Customer orientation

Our Management is committed to identifying and fulfilling customer and regulatory requirements. For advanced fiber tools GmbH, determining customer satisfaction with the quality of our products and services is a key criterion for fulfilling and implementing our quality policy and objectives. Therefore, the quality department regularly conducts surveys to gather relevant market data regarding customer feedback on the safety, quality, and usability of our medical devices.

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.