Omsbar Ltd

Omsbar provides assistance in getting medical devices onto the market in the EU, USA and elsewhere particularly experienced in obtaining regulatory approvals providing active input as engineers into the realisation of the technical documentation, notably providing expert guidance in risk analysis and clinical evaluation. Experineced in software controlled electircally powered devices, standalone software devices, sterile single use devices and implantable devices and an excellent track record in working with Notified Bodies and the FDA

Omsbar is ISO13485 accredited in its own right and can form an integral part of the development and initial production of client projects without any additional Notified Body oversight. Omsbar has its own Class ISO Class 6 clean room and machine shop for producing prototype medical devices for assessment and clinical trials.

Omsbar has strong manufacturing links to transition from protoype to full scale manufacturing – with many years experience working in China

Omsbar provides feasibility studies assessing new medical device concepts and principles. A particular strength is converting conceptual requirements from such work into a regulatory approval pathway including the assessment and provision of biocompatability and sterilisation validation and implementation of clinical trials.

Omsbar has an excellent grapevine of industry, academic and clinical contacts to assist you in such work

Company’s Keywords:

medical device prototyping, clean room, medical device regulatory affairs, medical device design