A.M.I. develops and manufactures medical devices and implants for coloproctology, urology and urogynecology at its Feldkirch site.

A.M.I. Agency for Medical Innovations GmbH

Feldkirch (AT) · Lindau (DE) · Cergy (FR) · Marblehead, MA (USA)New on Amplifa

1998Founded

4Locations (Feldkirch, Lindau, Cergy, Marblehead)

103Countries with A.M.I. products

About A.M.I.

A.M.I. Agency for Medical Innovations GmbH, headquartered in Feldkirch (Vorarlberg, Austria), develops and manufactures medical devices for surgeons and hospitals worldwide. The product portfolio includes implants and instruments for coloproctology (including HAL-RAR systems such as TRILOGY, Soft Anal Band, Comfort Drain, FiXcision), urology (the ATOMS system for treating male urinary incontinence), as well as urogynecology and laparoscopic gynecology (including BSC Mesh, InGYNious, sensiTVT, More-Cell-Safe, i-Cut, MacroLux Seleneview). Product development takes place in collaboration with internationally recognized experts and surgeons; in addition, the company offers surgeons the implementation of their own product ideas including patent brokerage, as well as surgical workshops and trainings. Manufacturing covers non-active functional implants and soft tissue implants, active surgical devices, and non-active instruments and devices for injection, infusion, transfusion and dialysis. A.M.I. products are delivered to 103 countries; sales branches are located in Germany (Lindau), France (Cergy) and the USA (Marblehead, MA).

Site: Feldkirch
Processes: Product development / design for surgeons' ideas, Patent brokerage, Surgical workshops / trainings, Collaboration with internationally recognized experts and surgeons
Materials: Implants and soft tissue implants (meshes, bands, slings), Surgical instruments and devices
Certificates: ISO 13485:2016 / A11:2021 (DIN EN ISO 13485:2021), ISO 13485:2016 (MDSAP Audit Model Edition 2), EC-Certificate (MDD 93/42/EEC Annex II, Full Quality Assurance), EU Quality Management Certificate (MDR, Annex IX), EU Technical Documentation Assessment Certificate PFR Meshes, transvaginal (MDR), EU Technical Documentation Assessment Certificate PFR Meshes, transabdominal, ISO 13485, ISO 14001, ISO 45001, IATF 16949, EN 9100, ISO 13485 (MDSAP), MDR (EU 2017/745, Annex IX), Other
Founded: 1998
Industries: Medical technology, Coloproctology, Urology, Urogynecology, Laparoscopic gynecology, Bariatric surgery (morbid obesity)

01
Product development / design with surgeons
02
Manufacturing in Feldkirch
03
Quality management and certification (ISO 13485, MDSAP, MDR)
04
Distribution via branches in Germany, France, USA
05
Trainings / surgical workshops

Product Areas and Manufacturing

MED

Implants and soft tissue implants (meshes, bands, slings)

Non-active functional implants and soft tissue implants for coloproctology, urogynecology and urology.

DEV

Surgical instruments and devices

Non-active instruments as well as active surgical devices and devices for injection, infusion, transfusion and dialysis.

Locations

Feldkirch

Headquarters / Development / Production

Lindau

Sales branch Germany (A.M.I. Agency for Medical Innovations Deutschland GmbH)

Cergy

Sales branch France (A.M.I. France)

Marblehead, MA

USA

Sales branch USA (A.M.I., Inc.)

Products

**MacroLux Seleneview**Medical device · Urogynecology / Laparoscopic gynecology

**Quality Management Certificates**ISO 13485 / MDSAP · Quality assurance

Industries

Medical technologyColoproctologyUrologyUrogynecologyLaparoscopic gynecologyBariatric surgery (morbid obesity)Oncology

Additional services

Product development / design for surgeons' ideasPatent brokerageSurgical workshops / trainingsCollaboration with internationally recognized experts and surgeons

Reference customers

Landeskrankenhaus Bludenz (reference physician Dr. Matthias Scheyer)Klinik Tettnang (Dr. Christian Fünfgeld)Krankenhaus Emmendingen (Prof. Ulrich Baumgartner)Klinik Preetz (Dr. Achim Niesel)uro aktiv/Stadtklinik im Diako Augsburg (Dr. Volker Moll)St. Josef Krankenhaus Wien (Dr. Ulrike Satzinger)Semmelweis Frauenklinik der Krankenanstalt Rudolfstiftung Wien (Dr. Ayman Tammaa)ORTENAU KLINIKUM Offenburg-Kehl (workshop location)Oberschwabenklinik Westallgäu-Klinikum Wangen (workshop location)

Quality and Certifications

The quality management system at the Feldkirch site is certified to DIN EN ISO 13485:2021 (EN ISO 13485:2016/A11:2021) and within the framework of MDSAP; in addition, there is an EC certification under MDD Annex II (Full Quality Assurance) as well as EU quality management and technical documentation certificates under MDR Annex IX.

Evidence	Feldkirch
ISO 13485
ISO 14001
ISO 45001
IATF 16949
EN 9100
ISO 13485 (MDSAP)
MDR (EU 2017/745, Annex IX)
Other

History

1998
A.M.I. registered as a company; team of medical technology and industry experts established.
2000
HAL method introduced in Europe; sales branch Germany founded; acquisition of DUFOUR Medical S.A. in France.
2002
Innovation Prize of the State of Vorarlberg for the A.M.I. HAL System.
2004
Groundbreaking for the new headquarters in Feldkirch; Innovation Prize of Vorarlberg for the Anal Band.
2008
Extension building 'Innovation Facility'; MediKids childcare; US branch in Marblehead, MA; market launch of ATOMS.
2010
BSC Mesh introduced; Innovation Prize of Vorarlberg for ATOMS.
2013
TRILOGY – third HAL-RAR generation with Bluetooth technology.
2015
More-Cell-System (In-Bag Morcellation) introduced.
2017
SME Award, 1st place Trade and Craft.
2019
3rd place in Austria's Leading Companies; Seal of Excellence Family-friendly Company 2018-2019.
2020
2nd place in Austria's Leading Companies.
2021
Seal of Excellence Family-friendly Company 2020-2021.
2025
New MDR certifications for BSC Mesh, InGYNious, TRILOGY, i-Cut.