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The regulation of medical devices is a vast and rapidly evolving field that is often complicated by regulatory requirements. To validate your production practices to the international standard for quality management systems for medical devices, BV examine your quality management practices for medical devices, focusing on meeting regulatory and customer requirements, risk management, and maintaining effective processes, namely the safe design, manufacture, and distribution of medical devices. Benefit from the positive effects of a quality management system, an organization is capable to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The benefits of gaining management systems certification:

To meet regulatory requirements and customer expectations: national regulatory authorities usually strongly recommend the manufacturer’s medical devices have a third-party audited and certified management system in place or even become mandatory requirement.

To reduce cost and risk of hazards: the certification model can guide manufacturers through a product’s entire life cycle, including a formal assessments of a manufacturer’s risk management process, which reduce the cost during the production process and also the risks.

We can help you adopt the right training and certification services in the Medical Devices business, in order to ensure your services/products are safety and green in quickly, efficiently and cost effectively as possible.

Bureau Veritas offers a wide range of certification services that will help you meet the growing requirements and face the challenges of higher standards in Quality, Food Safety, Health & Safety, Environment and Social Responsibility. We have experts dedicated to every sector. Specialization allows our inspectors and auditors to better understand and assess your processes and deliver a high quality service.
 
 
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