Development and cleanroom production of medical devices: hemostatic agents, surgical meshes and functional implant coatings.
BioCer Entwicklungs-GmbH
Dieselstraße 15, 95448 Bayreuth · Ludwig-Thoma-Str. 36c, 95447 BayreuthNew on Amplifa
About BioCer Entwicklungs-GmbH
BioCer Entwicklungs-GmbH is a medical technology company founded in 1998 as a spin-off of the University of Bayreuth, headquartered in Bayreuth. The company develops, produces and distributes medical devices made from biomaterials free of animal or human components. The portfolio covers three areas: plant-based hemostatic agents (HaemoCer™) with associated applicators, surgical mesh implants as soft tissue substitutes (TiO₂Mesh™), and functional ceramic coatings of implant surfaces based on sol-gel technology. Production takes place as cleanroom production in accordance with DIN EN ISO 13485, and the products are approved in accordance with Regulation (EU) 2017/745 (MDR). BioCer also offers contract development and contract manufacturing for medical device manufacturers and distributes its products through a worldwide dealer network in around 80 countries.
- Site
- Bayreuth
- Processes
- Sol-gel coating of implant surfaces (dip or spray coating process), Heat treatment (conversion of the sol-gel layer into a ceramic layer), Cleanroom production of medical devices (hemostatic powders, surgical meshes, coatings), Manufacture of plant-based hemostatic agents (hemostatic powders, patches) including applicators, Manufacture of surgical mesh implants (TiO2Mesh) as soft tissue substitutes, Development and production of medical devices on behalf of customers (contract, Contract development and manufacturing of medical devices (TuE/TuP), Functional ceramic implant coatings (sol-gel technology: antibacterial, anti-allergic,
- Materials
- Titanium dioxide (TiO2) – ceramic coating / TiO2Mesh, Cobalt-chromium-molybdenum alloy (cited in the literature as a coating substrate), Copper-filled TiO2 coating (active filler), Plant-based, resorbable biomaterials (hemostasis, free of animal/human components), Titanium dioxide (TiO2), Cobalt-chromium-molybdenum alloy, Plant-based, resorbable biomaterials
- Certificates
- EN ISO 13485:2016 (incl. AC:2018, A11:2021), EN ISO 13485:2016
- Founded
- 1998
- Industries
- Medical technology, Surgery (visceral and hernia surgery), Endoscopy, Orthopedics/implant technology, Surgery (visceral surgery, hernia surgery)
- 01
Development of new biomaterials
- 02
Sol-gel coating of implant surfaces (dip or spray process)
- 03
Heat treatment (conversion into a ceramic layer)
- 04
Cleanroom production of the medical devices
- 05
Product approval (CE, MDR)
- 06
Distribution via a worldwide dealer network
Materials and Processes
Titanium dioxide (TiO2)
Ceramic coatings for implant surfaces with antibacterial, anti-allergic or bone-growth-promoting effects, as well as the basis of the TiO₂Mesh™ mesh implants.
Cobalt-chromium-molybdenum alloy
Cited in the scientific literature as a coating substrate for TiO2 ceramic coatings.
Plant-based, resorbable biomaterials
Basis of the HaemoCer™ hemostatic powders and patches, free of animal or human components.
Locations
Bayreuth (Dieselstraße 15)
DEDesign and development, production (cleanroom) and distribution
- Materials
- Plant-based biomaterials, TiO2 coatings
- Cleanroom production in accordance with DIN EN ISO 13485
Bayreuth (Ludwig-Thoma-Str. 36c)
DEAdministration
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Sol-gel coating of implant surfaces (dip or spray coating process)Surface | – | – | – | – | Metallic implant materials (e.g. Ti, Co28Cr6Mo according to |
| Heat treatment (conversion of the sol-gel layer into a ceramic layer)Heat treatment | – | – | – | – | TiO2-based coatings |
| Cleanroom production of medical devices (hemostatic powders, surgical meshes, coatings)Assembly | – | – | – | – | Biomaterials free of animal or human components |
| Manufacture of plant-based hemostatic agents (hemostatic powders, patches) including applicatorsAssembly | – | – | – | – | Plant-based, resorbable materials |
| Manufacture of surgical mesh implants (TiO2Mesh) as soft tissue substitutesAssembly | – | 30 x 30 cm | – | – | TiO2-based mesh material |
| Development and production of medical devices on behalf of customers (contractEngineering | – | – | – | – | Biomaterials |
Additional services
Quality and Certification
BioCer Entwicklungs-GmbH operates a quality management system in accordance with EN ISO 13485:2016 (certified by TÜV Rheinland, valid until 2027-06-07) and meets the requirements of Regulation (EU) 2017/745 (MDR). Production takes place as cleanroom production in accordance with DIN EN ISO 13485.
| Evidence | Bayreuth (Dieselstraße 15) | Bayreuth (Ludwig-Thoma-Str. 36c) |
|---|---|---|
| EN ISO 13485:2016 |
History
- 1998
Founding of BioCer Entwicklungs-GmbH as a third-party funded research company (spin-off of the University of Bayreuth)
- 2003
Close cooperation with the University of Bayreuth
- 2009
Company reorientation; certification of the development department in accordance with DIN EN ISO 13485; start as a medical device manufacturer
- 2010
Cleanroom production in accordance with DIN EN ISO 13485; CE approval of HaemoCer™ and TiO2Mesh™; market entry in Germany, Europe and Asia
- 2012
CE approval of the HaemoCer™ Universal Applicator
- 2013
Product innovation HaemoCer™ PLUS; CE approval of TiO2Mesh™ BRA; further approvals worldwide (Asia, Africa, USA, South America)
- 2014
Market entry in China
- 2018
CE approval for HaemoCer™ Patch and HaemoCer™ FlexApplicator
- 2019
Introduction of HaemoCer™ Universal SET and HaemoCer™ Flex SET; CE approval for TiO2Mesh™ light and TiO2Mesh™ BRA light
- 2020
CE approval for HaemoCer™ Endoscopic Applicator; introduction of HaemoCer™ Endoscopic SET