Compliance with industry regulation and legal requirements is fundamental to Bray’s success. We take pride in our commitment to consistently provide quality products.
Our quality policy states we commit to:
Bray Group works in compliance with:
MHRA registration is vital for healthcare products like ours demonstrating commitment to regulatory compliance and product safety. Compliance with the Human Medicines Regulations 2012, involves thorough assessments of manufacturing, quality control, and documentation all to meet the high standards set by the MHRA. It’s a badge of trust. MHRA registration signifies rigorous scrutiny, contributing to the safety and effectiveness of our healthcare products.
The Medical Devices Directive 93/42/EEC is a regulatory framework established by the European Union to ensure the safety and performance of medical devices. Bray was awarded this certification in 1998 and it was updated in 2019. Bray is now on a journey to MDR compliance and we are confident and ready for the robust MDR audit process during 2025.
Many of Bray’s products proudly bear the CE mark, a symbol of compliance with European Union (EU) regulations and a testament to our commitment to meeting high-quality and safety standards. The CE mark signifies that our products meet the general safety and performance requirements outlined by EU directives. It serves a clear indication that our products have undergone rigorous testing and adhere to the stringent standards set forth by European authorities. This reinforces our position as a reputable and compliant provider.
ISO 13485: 2016 accreditation was awarded to Bray in 2018. It is crucial for us as an organisation involved in the medical device industry to comply with this standard to ensure the quality and safety of our products. This certificate demonstrates a commitment to quality management and regulatory compliance, helping us meet legal and regulatory requirements and gain customer confidence. It facilitates access to global markets by aligning with international quality standards.