Quality

Oscar Boscarol srl developed its Quality system accordingly to ISO 9001 (Quality Management Systems) and ISO 13485 (Medical devices – Quality Management Systems). The company acts and behave in compliance with all National laws besides European and local norms (when requested) referring to medical devices design, production, commercialization and after sale service. Particularly, the company aims to wholly follow and respect what required by 93/42/CEE European norm, ever since its first issue up to all revisions, modifications and later additions together with all reference rules and guidelines in due course. all class I devices of our production comply with the new regulation on medical devices MDR 745/2017. The next goal, within the expiry of the certificate, remains that of making devices of classes above I compliant with the regulation.

Our organization has always been involved in a process that might respect the environment and constantly applies measures and activities aiming the utmost level of eco-sustainability. Design and homologation of our medical devices comes from a pretty scarce compliance to customers queries and law requirements of many devices. One of Oscar Boscarol Company first goal has always been to design and manufacture specific products for this particular field, continuously updated in order to satisfy both customer and legal requests and prerequisites. The entire company organization is involved in a process dealing with continuous improvement where the customer’s satisfaction represents an indefeasible value.

Oscar Boscarol company has defined its quality management system as strategic mean to:

  • Satisfy quality policy and its specified goals.
  • Prove to be able to provide products compliant both to our customers and legal requirements alike on a regular basis, by efficiently applying the quality system itself.
  • Strengthen our tendency to prevent and eventually correct the causes of possible problems and intervene after the effects have been detected. Activate all procedures allowing to prevent, intervene and document all negative effects dealing with the use of medical devices (post-production information).

CONFORMITY CERTIFICATE

CE CERTIFICATE