European Union Regulatory, Technical, Legislative & Productivity Improvement Specialists
Client Support Team

Bernard J. Tremaine

Jim Mackenzie

Brian Quinn

Consultant in 93/42/EEC general Strategies
IRCA registered Lead Auditor (A007435)
Active Medical Devices Specialist

  • Electrical Safety
  • Vital Signs Monitoring
  • Life Support Equipment
  • Catheterisation
  • Laboratory Catheterisation
  • Quality Assurance
  • Regulatory Assurance
  • Stress Test Systems

 
 
 

 

 

 

Consultant in 93/42/EEC general Strategies
registered Lead Auditor 
Active Medical Devices Specialist

  • Medical Equipment 
  • Product Registrations
  • Sterile Products 
  • Computer hardware & Software
  • Medical Disposables 
  • Medical Electronics 
  • ISO 9000 / EN 46000 Quality systems
  • In Vitro Diagnostics 
  • Regulatory Affairs
  • Medical Devices Directives 
  • Process Validation
  • In Vitro Diagnostics Directive Sterilisation Methods
  • FDA cGMP (QSR) Total Quality Management
  • Training Auditing
  • Clinical Trials Clean-rooms

Technical Specialist/ Assessor

  • Medical Devices Industry
  • Health & Safety
  • Personnel Protective Equipment
  • Environmental
  • Quality Management Systems
  • EN/ISO 9000, EN46000 
  • Council Directive 93/42/EEC
  • CE Mark Auditing


 
 

 

 
 

 

 

 

 

 

Alan Taylor

Garth Berry

John Yates

              Awaiting photo

Technical Specialist / Assessor
 Regulatory Affairs

·         Quality Control

·         Microbiology & Sterilisation

·         Clinical Trials

·         New Product Development

·         Project Management

·         Market Research & Strategy

·         Wound care and wound closure

·         Infection control

·         Intra venous catheter & catheter retention

·         Dental products

·         Incontinence care

 

 

Technical Specialist / Auditor

  • Medical Device & Drug Related Industry
  • Customer Focus 
  • Project Management
  • Quality Management Systems
  • EN/ISO 9000, EN46000 
  • Council Directive 93/42/EEC
  • CE Mark Auditing

 

 

 

 

 

 

 

Technical Specialist/Assessor

  • Developing the Effective Manufacturing Systems & Utilising Technology 
  • Cost Controls - Controlling & reducing Your Production & Related Costs 
  • Improved Production & Improved Efficiency - Making More for Less 
  • People Management - Methods for Motivating & Getting the Best from Your Staff
  • Asset Management Control to Deliver Better Returns 
  • Improving Production Performance & Generating Additional profit

 


 

Paul Shane Bennetts MCIM, FFA.

Michael J. Bennetts

Stephen Crisp

    Awaiting photo

 

Project Management & MD

  • Customer Focus
  • Project Management
  • Technical Guidance
  • Medical Devices Directive 93/42/EEC
  • Ex-Medicinal Devices
  • Drug related Devices
  • Business Development & Management
  • CE Mark Auditing
  • Authorised Representative

 

Operations Director

  • Management
  • Sales Distribution
  • Purchasing

 


 


 
 

 

 

 

 

 

Technical Specialist / Assessor / registered Lead Auditor 

  • Medical Device & Drug Related Industry
  • Orthopaedic Devices 
  • Related Medical Devices
  •  Clinical trials & Evaluations
  • Quality Management Systems
  • EN/ISO 9000, EN46000 
  • Council Directive 93/42/EEC
  • CE Mark Auditing

 

 

Edwin Fleming

Steven Deeks

 

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Literature Research Specialist

  • Medical Devices
  • Urology
  • Animal Tissue
  • Stents
  • Wound Management
  • Catheters
  • Microbiology & Sterilisation

Drug Related Devices

Awaiting photo

 

Electronic Sales & Database Specialist

  • Web Sites
  • Database development
  • E Mail Servers

Keeping your Business Up to Date & In Compliance with
The Latest UK, European Union Legislation & USA requirements.
Better Regulatory Compliance Advice & Hands-on Help, Better Industrial Practise &
A Better Future for You, Your Colleagues & for Your Staff.