Quality and Regulatory

Pursuit of Excellence

Owen Mumford is widely recognised for our expertise in maintaining high-quality standards in the development and manufacturing of medical devices. With a strong emphasis on quality, we have built a reputation as a trusted provider of reliable and safe healthcare solutions.

At the core of Owen Mumford's quality expertise is a commitment to meeting and exceeding regulatory requirements and industry standards. We adhere to strict quality management systems and processes throughout our operations to ensure consistent quality control at every stage of product development, from design and manufacturing to distribution and post-market surveillance.

Navigating the complexities of compliance

Owen Mumford's regulatory expertise is a critical aspect of our commitment to delivering high-quality medical devices that meet global regulatory standards. Through our deep knowledge, proactive approach, and collaborative efforts, we ensure compliance, by successfully navigating the ever-evolving regulatory landscape, ultimately benefiting patients and healthcare providers worldwide.

Due diligence

Our locations are audited and inspected multiple times each year, and our customers are also welcome to inspect our premises. We have an excellent compliance record for ISO13485 requirements, and our quality team continually help drive improvements, which is beneficial for our pharmaceutical partners and the users of our devices.

Post-launch support

Our regulatory affairs team closely monitors evolving regulatory guidelines and requirements to ensure compliance with all applicable regulations. They work collaboratively with internal stakeholders, regulatory authorities, and industry associations to stay up-to-date with the latest regulatory developments. This proactive approach allows Owen Mumford to anticipate regulatory changes, adapt our strategies accordingly, and maintain our products' regulatory compliance throughout their lifecycle.