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Medical Devices – Clinical Requirements for Regulatory Compliance Print E-mail
An intensive 1 day course providing  an overview of the regulatory requirements for clinical evaluation data, the approaches for generating appropriate clinical evidence, and the processes involved in conducting clinical trials.

Background
To meet both US and EU medical regulation, manufacturers placing products on the market have to provide clinical evidence to support their regulatory submission. Previously, interpretation and implementation of these requirements have varied considerably, however with the implementation of ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects – and the issue of the recast Medical Devices Directive, Notified Bodies and regulators are requesting comprehensive clinical evaluations for all classes of device, with increasing attention being paid to the quality and conclusions of clinical evidence.

Who should attend?
  • Senior Management
  • Product Managers
  • Medical Device Regulatory Affairs Professionals
  • Clinical Affairs Professionals
  • Quality Assurance Professionals
  • Product Designers

Learning Objectives
The purpose of this 1 day course is to provide delegates with an overview of the requirements for clinical data, both in the EU and US. Delegates will also learn about the structure and requirements of ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects; the use of both Literature review and Clinical investigation, and an overview of the process of conducting a clinical trial

Course Details
The course presents ISO 14155 requirements comprehensively, and uses interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course. 
Delegates receive a "Certificate of Attendance".

Contact us for detailed training agenda and prices
 

Latest News

Regulatory Updates

Two new guidance documents on Clinical Investigation: MEDDEVs 2.73/3 & 2.7/4

14-12-2010

FDA CDER (&CBER & CVM) Guidance for Industry: Process Validation: General Principles and Practices

24-11-2011

FDA CDRH: Medical Device Innovation Initiative

February 2011
 
Our 2010 Success

Although the 2010  economy was a difficult year for many businesses, we can look back with justified pride in our success and draw confidence that we can improve and grow our services to the health care industry in 2011, nationally and internationally.

Here are some brief statistics on our 2010 activities, which are indicative of our ongoing success

  • we provided major services to more than 24 medical device and drug facilities
  • we agreed service contracts with 12 new companies
  • we trained over 250 people in the industry, including Competent Authority personnel
  • we successfully project managed 3 FDA compliance inspections in the UK and China
 
Smithers UK (formally RAPRA) partners with Medicom
Medicom has successfully renewed its contract for 2011 with iSmithers to provide bespoke training for medical device polymer suppliers
 
DS Certificering A/S partners with Medicom
Medicom successfully renews contract for 2011 with DS Certificering A/S to provide public and in-house medical device training courses in Denmark.

Public Training Courses

Book now to secure your place on our remaining public training courses in 2011 Dates to be announced soon

Process Validation
Device Design
QS Regulation

Book now to secure your place on our remaining public training courses in 2011 at iSmithers, UK.

Medical Device Legislation and Material Selection

14-15 June

Shawbury, Shropshire, UK.

15-16 November

Shawbury, Shropshire, UK.

Book now to secure your place on our remaining public training courses in 2011 at DS Certificering, Copenhagen, Denmark.

Process Validation

3 May
Copenhagen, Denmark

Medical Device Design and Development Control

4 May
Copenhagen, Denmark

Establishing Compliance With ISO 11135-1:2007 for Validation of Ethylene Oxide Sterilization

5 May
Copenhagen, Denmark

 

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