Development and production of microsurgical instruments for ophthalmic surgery in Swiss quality.
Bürki inno med AG
Widnau, Switzerland · Heidelberg, GermanyNew on Amplifa
About Bürki
Bürki inno med AG is an independent Swiss family-owned company founded in 1995, based in Widnau (Canton of St. Gallen). It develops and produces high-technology microsurgical instruments for ophthalmological surgery. The portfolio includes reusable and single-use irrigation/aspiration instruments (I/A systems) in sizes 20G to 23G, including bimanual systems with oval or high-flow variants, as well as monomanual Coaxial Safe-Lock systems with metal and silicone sleeves. In addition to proprietary branded products, the company acts as an OEM partner, offering design, development, and production of complex instruments and device systems, such as vitrectors with electromagnetic drive. Production combines automated assembly with manual manufacturing of high-precision instruments; materials include aluminum and silicone. Customers are renowned global medical technology companies as well as hospitals, clinics, and ophthalmologists worldwide. As an end product manufacturer, Bürki operates in compliance with EU Regulation MDR 2017/745; the European representative is Bürki inno med GmbH in Heidelberg.
- Site
- Widnau
- Processes
- Development and production of high-technology microsurgical instruments (OEM), Automated Assembly, Manual manufacturing of high-precision instruments, Manufacturing of Bimanual I/A Systems (reusable, 20G-23G, oval/high-flow), Manufacturing of Monomanual Coaxial Safe-Lock I/A Systems, Manufacturing of Single-Use I/A Sets (20G-23G), Development of electromagnetic cutters (vitrectors) with electromagnetic drive and, Design/Construction
- Materials
- Aluminum, Silicone (Sleeve Variants), Silicone
- Certificates
- ISO 9001, EN ISO 13485
- Founded
- 1995
- Industries
- Medical Technology, Ophthalmic Surgery/Ophthalmology, OEM System Suppliers, Ophthalmology (Ophthalmic Surgery), Hospitals/Clinics
- 01
Engineering/Development
- 02
Production
- 03
Automated Assembly
- 04
Manual Fine Assembly
- 05
Documentation and Validation (MDR 2017/745)
- 06
Complaint/Return Management
Materials & Processes
Aluminum
Material for handles and housings, e.g., in I/A handles and electromagnetic cutters.
Silicone
Material for sleeve variants of the Safe-Lock I/A systems.
Locations
Widnau
CHHeadquarters, Production, Engineering
- Lot size
- Prototypes to series
- Materials
- Aluminum, Silicone
Heidelberg
DEEU Representation / EU Importer (Bürki inno med GmbH)
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development and production of high-technology microsurgical instruments (OEM)Engineering | – | – | – | – | Aluminum |
| Automated AssemblyAssembly | – | – | – | – | – |
| Manual manufacturing of high-precision instrumentsAssembly | – | – | – | – | – |
| Manufacturing of Bimanual I/A Systems (reusable, 20G-23G, oval/high-flow)Assembly | – | – | – | – | – |
| Manufacturing of Monomanual Coaxial Safe-Lock I/A SystemsAssembly | – | – | – | – | – |
| Manufacturing of Single-Use I/A Sets (20G-23G)Assembly | – | – | – | – | – |
| Development of electromagnetic cutters (vitrectors) with electromagnetic drive andEngineering | – | – | – | – | Aluminum |
Additional services
Reference customers
Quality
As an end product manufacturer, Bürki documents and validates all internal and upstream processes, including suppliers, according to EU Regulation MDR 2017/745. Since 1998, a quality management system according to ISO 9001 and EU Directive 93/42/EEC has been in place.
| Evidence | Widnau |
|---|---|
| ISO 9001 | |
| EN ISO 13485 |
History
- 1995
Martin Bürki founded the company as a sole proprietorship with single products for ophthalmologists; focus on first-generation reusable aluminum I/A handles and choppers.
- 1996
Start of development of the first electromagnetic cutters (vitrectors) made of aluminum.
- 1998
Introduction of a quality management system according to ISO 9001 and EU Directive 93/42/EEC.
- 2000
Development of the Megavit line with electromagnetic drive and cutting head systems.
- 2003
Reorganization into a stock corporation under Swiss law.
- 2004
Development and design of the first single-use products.
- 2011
Martin Bürki enters into a partnership with Gianni Müller.
- 2014
Move to the new company building at Industriestrasse 67 in Widnau.