QA & Regulatory

A philosophy of excellence in all areas

All successful companies have a commitment to Quality. Owen Mumford has adopted a philosophy of excellence in all areas. It is our aim to develop and continuously improve our products and systems. As part of this philosophy, the Corporate Quality Assurance Group is independent from manufacturing, development and sales to ensure compliance with the following industry standards:

• ISO 13485 Certification
• FDA CFR 820
• Medical Device Directive 93/42/EEC Annex II (excluding section 4) and Annex V
• CMDCAS 13485

Our notified body is SGS International Accreditation Services (Notified body No 0120) by whom we are regularly audited.
We are also inspected by the FDA.

Competencies include:

• Material testing
• Full process validation
• Benchmark testing
• Customer technical support
• Supplier assessment/validation
• Ability to complete or assist with regulatory strategy and submissions including Technical Files, under the Medical DeviceDirective 93/42/EEC and FDA 510 (K)
• Co-ordination, review and approval of FMEA/Risk Analysis/Risk Benefit Analysis