Clinical Evaluation for Medical Devices - a 2 Day Advanced Course

About this course

This course is designed to advance your skills in conducting systematic literature searches, appraising data and ensuring the clinical evidence collected is acceptable to the regulatory authorities or notified bodies reviewing it. The course provides you with opportunities to practise the literature review process and learn the scientific techniques including basic statistical considerations. It also introduces you to the requirements for clinical evaluations and literature reviews in other countries including those outside Europe such as the USA and Australia.

What You Will Learn

At the end of this two-day advanced course you should be well versed in the systematic literature review process and be able to produce high quality clinical evaluation reports. You will know how to conduct a systematic literature review and how to structure and build all the necessary documents which form part of the clinical evaluation process. At the end of the course you should clearly understand the following:

• How to select objectives
• How to identify key questions and keywords
• How to select and search databases
• How to do a manual search
• How to filter abstracts
• How to appraise (value) and weight articles
• How to evaluate the literature
• How to manage references and how to obtain full text article
• How to appraise clinical studies
• How to select comparator devices
• How to ensure quality throughout the process

Who Should Attend

This course is intended for those who have already been involved in putting together a clinical evaluation and have some knowledge of the whole process. The course is aimed at an advanced level and therefore only those who have already attended the precursor courses to this one or have experience of conducting reviews should consider enrolling.

This course forms part of the ‘Clinical Evaluation for Medical Devices’ suite

Enjoy a discount by attending more than one course in this suite:

All Courses = £2146.50 excl. VAT (5 days)
Both two day courses= £1620.00 excl. VAT (four days attendance)
The one day course + one of the two day courses = £1255.50 excl. VAT (three days attendance)

Course outline

• A detailed review of the clinical evaluation process, planning, developing and reporting
• Examination of the systematic literature review process
• Selecting databases and conducting searches and utilising other resources
• How to choose equivalent products, what to look for and how to compare
• How to clarify the question/s on which you need to find literature including devising the most comprehensive literature search strategy and selecting keywords
• Statistical input and considerations
• What notified bodies look for when reviewing the report – meeting their expectations and quality assurance of the final report
• A review of country-by-country requirements

Venue

AMP Technology Centre, Sheffield, UK

We have selected the AMP Technology Centre in Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in Healthcare Manufacturing Technologies and supported by Clinical and Academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham, Leicester it is a convenient and accessible location. The centre has been designed to accommodate a range of manufacturing-related activities, from fledgling engineering and technology companies, to University spin-offs and subsidiaries of established companies. Like NSF DBA the site has also been selected to create a community of some of the worlds foremost advanced manufacturing technology businesses, Rolls Royce, Boeing and Sheffield University.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Janette Benaddi
  NSF-DBA Medical Devices Consultant
  

  • [email protected]
  • +44 (0) 1143 600868

What you've said

This is a new course for NSF-DBA in 2012 and we will soon be able to provide you with feedback from our Medical Device program