Quality Management Systems

A pragmatic approach to quality management systems to international standards

MDC provides experienced quality management systems advice and assistance for medical device companies throughout Europe, North America and beyond

Services provided are wide ranging and include, but are not limited to:

• Implementation, audit, and improvement of existing ISO 9001 and 13485 Quality Management Systems (QMS) and how to upgrade them.
• Preparing companies for certification audits and US FDA inspections. Resolving issues with auditors or investigators following an audit / inspection.
• Providing internal audit advice, guidance, and other assistance with implementation.
• Helping with supplier and internal audits.
• Providing specialist assistance with cleanroom validation, especially when higher risk or combination products are involved.
• Providing specialist assistance for in vitro diagnostic (IVD) manufacturers.
• Recommending or signposting you to other professionals you need.

If you would like to know more about how our knowledge and pragmatic approach to quality systems can enhance and reinforce your medical device proposition, please feel free to contact Trevor Lewis now