Manufacturing of DORO® cranial stabilization and retractor systems for neurosurgery at the Freiburg site
Black Forest Medical Group GmbH & Co. KG
Freiburg im Breisgau · Cape Coral, FL (USA)New on Amplifa
About Black Forest Medical
The Black Forest Medical Group is a family-owned medical technology company founded in 1995 and based in Freiburg im Breisgau, specializing in cranial stabilization and brain retraction. Under the DORO® brand, skull clamps, head fixation systems and retractor systems for neurosurgery are developed and manufactured – from infants to seniors, for standard operating tables, carbon fiber table surfaces, and imaging environments such as iCT, iMRI and angiography. The systems are manufactured at the headquarters in Freiburg as well as at selected partner companies in Switzerland and the USA. Materials include stainless steel, aluminum and carbon fiber; some systems feature a sterilizable Teflon® coating. Manufacturing follows certified processes with a strict quality management system (MDR, MDSAP). After the integration of Feinmechanik GmbH in 2016 and the merger into the Black Forest Medical Group in 2019, the company moved into its new headquarters in Freiburg in 2021. Products are distributed in more than 70 countries.
- Site
- Freiburg im Breisgau
- Processes
- Manufacturing of DORO® systems at the German headquarters as well as at selected partners in, Own production unit (integration of Feinmechanik GmbH in 2016, merger of Pro Med, Multi-stage product development process for medical technology systems, Certified manufacturing processes with strict quality management system (MDR, MDSAP certified), Teflon® coating of system surfaces (machine-washable and autoclavable, sterilizable, Manufacturing of radiolucent head fixation systems (radiolucent, for, DORO® Service Center (repair/service, Cape Coral, Florida), Service Center (USA, Cape Coral)
- Materials
- Stainless steel (for navigation tooth rings/starbursts), Aluminum (DORO® QR3 aluminum head fixation system), Teflon® coating (PTFE, DORO® QR3 TEFLON), Carbon fiber (CFRP pads/tabletops, radiolucent products), Stainless steel, Aluminum, Teflon® coating (PTFE), Carbon fiber (CFRP)
- Certificates
- MDR QM Certificate (MDR2017Q, EU quality management system), MDR Product Certificate (MDR2017P), MDSAP (MDSAP16), EU MDR QM certificate (MDR2017Q), EU MDR product certificate (MDR2017P), ISO 9001
- Founded
- 1995
- Industries
- Neurosurgery, Medical technology, Intraoperative imaging (iCT, iMRI, angiography)
- 01
Engineering / product development (multi-stage process)
- 02
Manufacturing at the Freiburg headquarters as well as at partners in
- 03
Surface finishing (Teflon® coating)
- 04
Assembly of the DORO® systems
- 05
Quality inspection per MDR/MDSAP
- 06
Service & repair (Cape Coral Service Center)
- 07
Sales and training worldwide
Materials & Processes
Stainless steel
Used for navigation tooth rings (starbursts) on the skull clamps for high navigation precision.
Aluminum
Material of the DORO® QR3 head fixation system, the standard solution for cranial stabilization.
Teflon® coating (PTFE)
Coating of the DORO® QR3 TEFLON surfaces for machine cleaning and autoclavability.
Carbon fiber (CFRP)
Material for radiolucent pads and tabletops in imaging environments.
Sites
Freiburg im Breisgau
DEHeadquarters, production and engineering
- Materials
- Stainless steel, aluminum, carbon fiber, PTFE
Cape Coral, FL
USSales, service and DORO® Service Center (Black Forest Medical North America, Inc.)
Components & Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing of DORO® systems at the German headquarters as well as at selected partners inAssembly | – | – | – | – | Stainless steel, Aluminum, Carbon fiber, Teflon (PTFE) |
| Own production unit (integration of Feinmechanik GmbH in 2016, merger of Pro MedEngineering | – | – | – | – | – |
| Multi-stage product development process for medical technology systemsEngineering | – | – | – | – | – |
| Certified manufacturing processes with strict quality management system (MDR, MDSAP certified)Testing | – | – | – | – | – |
| Teflon® coating of system surfaces (machine-washable and autoclavable, sterilizableSurface | – | – | – | – | Teflon (PTFE) |
| Manufacturing of radiolucent head fixation systems (radiolucent, forAssembly | – | – | – | – | Carbon fiber |
| DORO® Service Center (repair/service, Cape Coral, Florida)Assembly | – | – | – | – | – |
Additional services
Quality & Certifications
DORO® systems are manufactured according to certified production processes and a strict quality management system. The company is certified under EU MDR (QM certificate MDR2017Q, product certificate MDR2017P) as well as under MDSAP.
| Evidence | Freiburg im Breisgau |
|---|---|
| EU MDR QM certificate (MDR2017Q) | |
| EU MDR product certificate (MDR2017P) | |
| MDSAP (MDSAP16) | |
| ISO 9001 |
History
- 1995
Official registration of the company in the commercial register as a GmbH by Dorothea Schüle
- 1998
Market launch of the DORO® brand and the DORO® product line, named after Dorothea Schüle
- 1999
Edgar Schüle takes over management of the company
- 2000
The first proprietary head fixation system comes to market
- 2003
Product launch of the first proprietary radiolucent head fixation system; opening of the US branch in Cape Coral, Florida
- 2007
PMI sells more than 250 products in over 70 countries
- 2011
Market launch of the DORO® QR3 skull clamp; Matthias Schüle takes over management of the company
- 2014
Introduction of the DORO LUCENT® skull clamp and the DORO LUNA® retractor system
- 2015
20 years of Pro Med Instruments; DORO LUNA® receives the innovation award of the City of Freiburg
- 2016
Integration of Feinmechanik GmbH – PMI gains its own production unit and more than 30 new employees
- 2017
Market launch of iCT and iMRI solutions; Roman Maier becomes Managing Director Operations
- 2019
Merger of Pro Med Instruments and Feinmechanik GmbH to form the Black Forest Medical Group; opening of the modernized DORO® Service Center in Cape Coral
- 2020
Groundbreaking for the new headquarters in Freiburg
- 2021
Move into the new headquarters in Freiburg
- 2022
DORO® XTom Cranial Stabilization System complements the imaging portfolio
- 2024
Gert Weber becomes Managing Director; market launch of the DORO LUCENT® Skull Clamp as the first "Next Gen" product; cooperation with IMRIS/Deerfield Imaging for a Cranial Stabilization Set for intraoperative MRI