Medical device consultancy

The Medical device consultancy (MDC) section specialises in delivering advice and setting up processes linked to the management of medical devices within healthcare organisations from small clinics to large scale trusts and PCTs.

MDC also has use of a small workshop team, offering services of mechanical and electrical design and manufacture of devices as well as carrying out specialised mechanical repairs.

Services

Consultation on medical device training programmes linked with procurement

  • How to engage industry to support device training within organisations
  • Core NHS issues – competence, risk management & infection control
  • Corporate & role specific induction training
  • Maximising capital procurement projects by ensuring training is sustained over the lifespan of awarded contracts
  • How to ensure training is training and not just a demonstration
  • Development of tailored e-learning tools supporting device training

Development of competency assessment tools (standardised documentation)

  • Liaison with clinical education teams
  • Competency reviews
  • Medical device training criterion
  • Assessing risk, determining training frequency
  • Self assessment tool development

Consultation on NHSLA core standard requirements applied to levels 1,2 & 3

  • Standard 2 – Competent & capable workforce – documentation, process & monitoring solutions (medical devices training)
  • Standard 3 – Safe environment – documentation, process & monitoring solutions (maintenance of medical devices & equipment)
  • Non-clinical auditing

Central Alerting System (CAS) alert organisational management – National Patient Safety Agency (NPSA), Estates and Facilities Alerts(EFA), Medicines and Healthcare Regulatory Alerts (MHRA) and Medical Device Alerts (MDA)

  • Policy documentation
  • System development “How to raise organisational compliance”
  • Alert compliance auditing
  • Utilisation of procurement teams
  • Accountability processes & escalation procedures
  • Developing the Medical Device Liaison Officer (MDLO) role
  • Managing Field Safety Notices (FSN’s)
  • I.T. solutions
  • Training in the above

Medical device adverse incident management

  • Creating links with industry & regulatory organisations
  • Investigation
  • Serious untoward incidents
  • Root cause analysis
  • Failure mode effect analysis
  • Conclusion & feedback (reporting & learning)
  • I.T. solutions
  • Training in the above

Electro mechanical device design and prototyping

  • ISO 13485 accredited
  • Bespoke firmware and software development
  • Complete service from idea to working product
  • Technical support, advice and consultancy

Contacts

Giovanni Gambaruto
Medical Devices Coordinator
T: 020 8725 1530
E: giovanni.gambaruto@stgeorges.nhs.uk

Mr. Ricardo Maynard
Medical devices training coordinator
MHRA Medical device & Deputy CAS Liaison officer
Medical device incident coordinator
T: 020 8725 1141
E: ricardo.maynard@stgeorges.nhs.uk

Mr David Tropman
Clinical Bioengineer
T: 020 8725 2669
E: david.tropman@stgeorges.nhs.uk