Quality Management Systems

A pragmatic approach to quality management systems to international standards

We provide 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 and how to upgrade them.
  • Preparing companies for certification audits and US FDA inspections, or resolving issues with auditors or investigators following an audit / inspection.
  • Providing internal audit advice, guidance or direct assistance with implementation.
  • Providing assistance with supplier audits.
  • Providing specialist assistance with cleanroom validation and/or pharma requirements, especially when higher risk or combination products involved.
  • Providing specialist assistance for in vitro diagnostic (IVD) manufacturers.

If you’d 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 us here.

We provide specialist advice and assistance for medical device companies throughout Europe, North America and beyond…

Should you require any further information simply call us on 01630 67 37 37