Quality & regulatory services
Pursuit of excellence
At Owen Mumford, we are widely recognised for maintaining high standards in the development and manufacturing of medical devices. With an 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, providing 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 first-class medical devices that meet global regulatory standards. Through our deep knowledge, proactive approach and collaborative efforts, we guarantee compliance by successfully navigating an ever-evolving regulatory landscape.
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 ISO 13485 requirements, and our quality team continually help drive improvements, which benefits both our pharmaceutical partners and the users of our devices.
Post-launch support
Our regulatory affairs team closely monitors evolving regulatory guidelines and requirements to establish compliance with all applicable regulations. They work collaboratively with internal stakeholders, regulatory authorities and industry associations to stay up to date with developments. This proactive approach allows Owen Mumford to anticipate regulatory changes, adapt our strategies accordingly and maintain regulatory compliance for all products throughout their lifecycles.
Accreditation and standards
We adhere to all relevant international standardisation guidelines, including the following.
Committed to quality
Our quality ethos throughout the organisation means all devices meet the rigorous standards that apply to the device, pharmaceutical and biotech industries. As such, our management system is set up to ensure that we are fully compliant with medical device regulations such as 21 CFR Part 820, ISO 13485:2016 and EU Medical Device Directive 93/42/EEC, as well as adhering to Good Manufacturing Practice (GMP).
Product warranty
At Owen Mumford, we are committed to delivering high-quality, reliable medical devices. To give you peace of mind and ensure continued satisfaction with our products, we offer comprehensive warranty coverage.