Business Wire India Bharat Rubber Works (BRW), one of India’s leading producers of primary packaging components, has recently received the European Union Medical Device Regulation (EU MDR CE) certification in compliance with the latest international regulations. The CE mark also provides the benefit of free movement of a product throughout the 30 member countries in the European Free Trade Area (EFTA) along with the assurance of high-quality products.
Being one of Asia’s first countries to receive ISO 13485:2016 (the latest version of the international standard for medical devices) & EU MDR 2017/745 (MDR CE), BRW’s certification stands as a testimonial to the quality products and systems the company has built over the last 40 years. The ISO 13485:2016 mark specifies controls for virtually everything involved in the lifecycle of a measuring device: from design through development and production to final use and servicing.
Siddharth Shah, Director, Bharat Rubber Works said, “It is a proud moment for all of us at Bharat Rubber Works to be one of the first companies in Asia to receive certification under new stringent regulations. It is the testimony of the quality products & systems we have built our organization over the last four decades. We are committed to continue building & delivering innovative and quality packaging solutions across the healthcare industry.”
The new regulations are significant updates on the directive and underlying requirements to support and follow stringent safety & quality protocols by competent national authorities & notified bodies. The certification also mandates basic UDI DI for all devices to enhance traceability across the supply chain, giving buyers complete transparency across their purchases.
Bharat Rubber Works’ measuring devices feature Plastic Dropper Assembly, oral dosing syringes, glass dropper Assembly, measuring/dosing spoons, and measuring/dosing caps. To become ISO 13485:2016 compliant, BRW underwent an evaluation process that included quality management system development, a management system documentation review & an audit to accomplish a new benchmark of the quality.
The EU MDR certificate is a true testament to Bharat Rubber Works’ strict code of conduct that boasts exemplary performance when it comes to managing stringent compliance policies, advanced quality check systems, robust complaint handling, regular product, customer feedback procedures, and trend reporting requirements with periodic safety updated reports.