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ISO 13485:2003 Print E-mail
An intensive one-day training course on how to establish and improve compliance with the GMP requirements of this standard for medical device manufacturers.

Background
The medical device industry is subject to increasing regulatory control, in order to meet these challenges it is vital to ensure the quality management system adequately address all requirements of ISO 13485:2003. This can only be achieved by ensuring that all personnel responsible for its implementation have the best understanding and competence to adequately interpret the various requirements.  This course offers the opportunity to consider in depth ISO 13485:2003 and provides specific insight into its application within the  medical device field. It adopts a practical approach to implementation at each tier of business processes, and features dedicated discussions of internal and external quality assessment and international regulation issues.
Learning Objectives

The course provides an excellent opportunity to fully understand

  • Reasons for change: standards & regulation
  • 8 quality management principles (ISO 9000:2000)
  • Business management & regulatory importance
  • Structure & content of BS EN ISO 13485:2003
  • Quality Management Systems - general requirements, documentation & records
  • Management responsibility
  • Process mapping
  • Resource management
  • Product realization
  • Planning, design, development, purchasing, production
  • Measurement and monitoring
  • Measurement, analysis & improvement
  • Transition and implementation strategy
  • Internal quality auditing and EC directives
  • Test (optional)

Course Format
This course present the standard comprehensively and uses case studies and analysis of specific situations from real-life scenarios in typical medical device manufacturers.
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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