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Validation of Medical Device Software Print E-mail
An intensive 2 day course on requirements for validation of medical device software as contained in EN (IEC) 62034

Background
The coming amendments to the Medical Devices Directive concerning software and the FDA’s Quality System Regulation requirements for software as expressed in 21 CFR 820.30(g), 70(i), 75 all requires the manufacturer to incorporate software life-cycle processes into his quality system.
The new standard EN (IEC) 62304 Medical device software – software life-cycle processes is a tool to fulfil these requirements.
The standard provides a framework of life-cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. This standard provides requirements for each life-cycle process.

Learning Objectives
This course is designed to give delegates an understanding of the EN 62304 standard as a tool to fulfil the regulatory requirements defined in the FDA’s GMP/Quality System Regulation 21 CFR Part 820 for software and the Essential Requirements of the Medical devices Directive (93/42/EEC).

  • The 2-day course details the software validation requirements that need to be addressed during design control [21CFR Part 820.30(g)] and [§7.3 of the EN ISO 13485] for software developments
  • There will be sessions on software risk management, development life-cycle, architecture, design, software verification and validation.
  • Software validation of proprietary medical device products, subcontracted and off-the-shelf software will also be covered.
  • Incorporation of EN ISO 14971, Medical devices – Risk management – Application of risk management to medical devices and AAMI /TIR 32 Medical device software risk management into the software life-cycle processes will be shown
  • All current documentation of the FDA and EU software regulatory requirements will be included in the course binder.

Course Format
The format will include lectures, discussions groups and case studies.
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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