Quality & Regulatory Services
Pursuit of Excellence
At Owen Mumford, we are well known for upholding high standards in developing and manufacturing medical devices. By focusing on quality, we’ve earned a reputation as a trusted provider of safe and reliable healthcare solutions.
At the heart of Owen Mumford’s quality expertise is our dedication to meeting and exceeding regulatory requirements and industry standards. We follow strict quality management systems and processes across all our operations, making sure there is consistent quality control at every stage of product development – from design and manufacturing to distribution and post-market monitoring.
Managing Compliance Challenges
Owen Mumford's regulatory expertise is a vital part of our dedication to supplying top-quality medical devices that meet global regulatory standards. With our in-depth knowledge, proactive approach, and team effort, we ensure compliance by skillfully handling a constantly changing regulatory environment.
Due Diligence
Our locations go through multiple audits and inspections each year, and our customers are also invited to inspect our facilities. We have an outstanding compliance record with ISO 13485 requirements, and our quality team is always working to drive improvements, benefiting both our pharmaceutical partners and users of our devices.
Post-Launch Support
Our regulatory affairs team closely tracks changing regulatory guidelines and requirements to make sure we comply with all applicable regulations. They work together with internal teams, regulatory agencies, and industry associations to stay up to date on the latest developments. This proactive approach enables Owen Mumford to foresee regulatory changes, adjust our strategies, and maintain compliance for all products throughout their lifecycle.
Accreditation and Standards
We comply with all relevant international standardization guidelines, including the following.
Dedicated to Quality
Our organization’s focus on quality guarantees that all our devices meet the strict standards required in the medical device, pharmaceutical, and biotech industries. Our management system is designed to make sure we fully comply with medical device regulations like 21 CFR Part 820, ISO 13485:2016, and the EU Medical Device Directive 93/42/EEC, as well as Good Manufacturing Practice (GMP).
Product Warranty
At Owen Mumford, we are dedicated to providing high-quality, dependable medical devices. For your peace of mind and ongoing satisfaction with our products, we provide complete warranty coverage.