Omsbar Medical Device Design Manufacturing and Regulatory Services


Manufacturing
  Omsbar maintains a small manufacturing facility for low volume manufacturing and prototype production on behalf of Clients.
  This provides fully traceable facilities which are ISO9001/13485 compliant and conform to FDA QMS requirements. We specialise in producing low cost tooling and low volume manufacturing solutions which are particularly suited for intentional low-volume, start-up and proof-of principle manufacturing, essential for minimum investment, initial revenue generation.
  We also have experience with a range of equipment and disposables manufacturing organisations and can provide links to large-scale manufacturing in the UK, Europe, US and RoW for electronic equipment and sterile (single-use) disposables etc either for product launch or subsequent volume ramp-up. Naturally we provide full manufacturing QMS and regulatory services and can perform product and process FMECA (Failure mode, effect and criticality analysis) accordingly.