The Business Unit Komet Medical.

The company Gebr. Brasseler and its brand Komet were founded as early as 1923. To this day, the company has been owned by the founding family. With a shop floor of over than 480,000 sqft and more than 860 production units, Komet counts among the largest manufacturers in this sector worldwide. Another factor that decisively contributes to the success of the enterprise is its highly qualified, dedicated staff who know their markets and constantly strengthen the company and its products. Gebr. Brasseler has been developing and manufacturing motor-powered precision instruments for use in surgical drive systems since 1988. The comprehensive range includes surgical saw blades, rasps, burs, cutters, craniotomies and twist drills as well as diamond abrasives. The instruments comprised in the above listed product groups are used in

  • Orthopaedics/traumatology
  • Sternotomy
  • Minimally invasive percutaneous foot surgery
  • ENT and neuro surgery
  • Oral maxillofacial surgery
  • Ophthalmology
  • Podiatry | Chiropody | Nail care

The medical technology market is faced with many strict regulatory requirements. Consequently, these regulations present many obstacles prior to market entry. As a self-contained business unit within Gebr. Brasseler, Komet Medical is able to overcome these obstacles with its close cooperation between sales, product management, regulatory affairs and engineering. This cooperation proves to be an important advantage to both ourselves and our customers from the medical technology industry, resulting in a relatively short “time to market”.

Thanks to the all-encompassing partnership with our customers that is reflected in all our transactions, Komet Medical can offer its clientele a convenient all-in-one product and service package.

The founding family.

Innovation is the heart and soul of our corporate tradition.

My father and our uncles, the Brasseler brothers, who founded the company more than 90 years ago, were competent, quality conscious and above all passionately creative. They not only improved existing products and created groundbreaking new instruments for the dental sector, but also implemented pioneering production processes and optimized the distribution channels.

This is what we are still doing today, however on a much larger scale. Brasseler is not only an established innovation leader with one of the most comprehensive range of rotary instruments and systems in the dental sector worldwide, but also a renowned supplier of instruments for general surgery, dental technology and custom made tools. What’s more, Brasseler’s special know-how, precision and quality are also highly appreciated in the jewellery industry.

The success of the company is based on absolute reliability and the trust that we put in our staff, our customers and – last but not least – ourselves. We put a lot of thought into everything we do. Whatever we do, we do it right.

The 2nd and 3rd generation of the founding family: Our Corporate Partners Klara Niehus, daughter of Peter Brasseler Sen., and her daughters Anke and Kirsten.

The chronicle.

Gebr. Brasseler GmbH & Co. KG

Founded: 1923
Brand: Komet/Komet Medical
Independent family-owned company
Certificated according to: ISO 9001:2015, EN ISO 13485:2016 and ISO 13485:2016 (MDSAP)
FDA Establishment Reg No. 8010468
Staff: > 1,100 (headquarters), > 1,350 worldwide
Floor area: > 44,500 qm/480,000 sqft production area and office space
More than 860 production units

 

Capabilities

Production

  • 6-axis grinding machines
  • CNC controlled long automatic lathes (up to 32 mm)
  • Lathe/milling center with 5 simultaneous axes
  • Deep hole drilling (Q4 2019)
  • High-performance phase laser cutting of metal
  • Offsetting machines for the production of saw blades
  • Special installations for surface treatments (deburring/blasting)
  • Laser welding
  • Anodizing
  • Electropolishing
  • Heat treatment/Hardening
  • In-house electroplating shop / Diamond coating – 12 grit sizes
  • From 25 µ (500 mesh) to 851 µ (20 mesh)
  • Ultrasonic cleaning
  • Passivation (ASTM A967)
  • EDM-Wire cutting
  • Wire forming
  • CMM Inspection
  • Electrodynamic testing machine according to ASTM F1717, ASTM F2193, ISO 12189
  • Torsion testing machine according to ASTM F543, F1717, ASTM 1789
  • Gold plating
  • Color coding
  • Blasting installations (matting) for rotary instruments
  • Laser inscription (depth marking & inscription)
  • Clean room, ISO class 7 with validated packaging concepts
  • Warehousing

Product Range

  • Saw blades 
    Ground saw blades for knee endoprosthesis 
    Offset saw blades 
    Etched saw blades
  • Rotary instruments 
    Stainless steel 
    Tungsten carbide | All-tungsten carbide 
    Diamond
  • Drill bits/Twist drills | Cannulated drills
  • Pins & Screws for endoprosthesis
  • Cutters for minimally invasive percutaneous foot surgery

Documentation | Validation | Quality Control

  • FMEAs | Risk management
  • Process validation
  • Cleaning validation
  • Packaging validation
  • Statistical process control (SPC/CAQ)
  • CAD/CAM integrated process between construction and production

Quality Management.

Gebr. Brasseler GmbH & Co. KG has a Quality Management System in place which is certified according to standards ISO 9001:2015, EN ISO 13485:2016 and ISO 13485:2016 (MDSAP) for the development, manufacture and distribution of medical and industrial products.

This serves predominantly to ensure that all corporate procedures are focused on compliance with the wishes and expectations of our customers.

As you can see, the fulfilment of even the highest customer expectations is not left to chance, but is based on clear, concise guidelines and procedures. The resulting quality can therefore be reproduced at any time.

Certificates

ISO-13485:2016 (MDSAP)

valid until 18.10.2021

ISO-13485:2016

valid until 19.01.2020

ISO-9001:2015

valid until 19.01.2020

Directive 93/42/EEC

valid until 19.01.2024

AEO Certificate

 

Regulatory.

Anyone active in the medical technology sector knows how important the regulatory aspect has become. National and international standards, laws and directives have to be complied with – and these are subject to constant change. A specialized team ensures that the required Technical Documentation is compiled and updated according to valid regulations right from the start. We have all relevant documents and information ready at hand and can provide these to our customers or even compile them according to requirements - at very short notice.

Contract Manufacturing Solution
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