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MEDICAL DEVICE DESIGN
LASER MICROWELDING CENTER


BREDAM SA services are based on a detailed know-how in medical device design and development, in particular in the ENT and gastroenterology fields. Design activities, as prototyping, pre-series manufacturing, industrialization and product technical documentation are our core activities.

BREDAM SA has a strong expertise in biocompatible materials handling and assembling, in particular biocompatible metals and metallic alloys, thermoplastics and silicones.
A real expertise has been developed in assembling techniques, such as LASER microwelding and all types of bonding, as well as in LASER marking and electrolytic marking.

  • Controlled and documented medical device design process, according to ISO 13485
  • Product technical file compliant with medical regulation, according to EU MDD DIR 93/42/EEC and US FDA 21CFR 820
  • Product risk management, according to ISO 14971
  • Industrialization – development of specific equipment – set-up of dedicated production lines
  • In-house micromechanics workshop which allows realizing prototypes and tooling during the initial stages of product design
  • Network of specialized partners and suppliers


Developments realized at BREDAM SA:
Savary-Gilliard® esophageal dilator (Cook Medical)
Savary-Gilliard® Wire Guide for use with esophageal dilator (Cook Medical)
HDR bougie for radiological treatment of esophageal cancer (Nucletron)
Oesotest® (Actimed)
R&D Medical