Compliance servicesomsbar 3x squares icon

Omsbar’s ISO13485 accreditation with a major UK Notified Body permits Omsbar to effect CE marking on behalf of clients, subject to some contractual provisions. All other services provided are carried out within the ISO13485 environment and this facilitates the migration of these services into the client’s own quality management system where appropriate. Our accreditation certification is shown on our home page.

 

Quality systems and regulatory affairs

Directives require that companies operate a quality management system to ensure that all products released for use conform to essential requirements both in terms of not only the product design and its validation but also its manufacture to ensure that ...

Read about the requirements, and Omsbar's capabilities