
MICROBIOLOGY ADVISORY PROGRAM
Development of an effective contamination control system is essential in aseptic, terminally sterilised and non-sterile medical device manufacture also many re-useable devices requiring reprocess before continued use constituting a critical factor in qualification and subsequent control of product to ensure safety, quality and performance.
QFI has extensive experience in laboratory testing, residual testing, disinfection studies, biological safety and cleaning, disinfection and sterilisation. The Microbiology Advisory Program (MAP) provides all the benefits you would expect from Europe’s leading consultancy, ensuring that you can demonstrate that your microbiological contamination level is documented, trended and appropriately controlled and fulfils the appropriate regulatory requirements.
QFI’s specialists can help in the following key areas:
- determining microbiological requirements for placement of medical devices on the market
- advice, organisation and co-ordination of sterilisation validation and routine cycles
- specialist protocol and report preparation and review
- defining controls for product release
- developing practical, cost-effective testing
- defining controls for hygiene and environmental control
- preparation of procedures
- regulatory support, including conformity and microbiological risk assessment
- on-site attendance and support during customer, Notified Body, MDSAP, MHRA and FDA audits and inspections
- vendor and sub-contractor audits