Medicom Consulting

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Ireland and UK

Irish Medicines Board (the NCA in Ireland)

Irish Medical Devices Association

UK Medicines and Healthcare Products Regulatory Agency

UK Association of British Healthcare Industries Limited

Regulatory Agencies in Europe, Canada, Japan and Australia

European Commission Enterprise & Industry Medical Devices

MEDDEV: Guidelines

Harmonised Standards

Team NB

National Competent Authority(s)

Notified Bodies (when page opens click on .pdf link beside 92/42/EEC to get NB listing)

PMDA Pharmaceuticals and Medical Devices Agency, Japan

Health Canada

Australian Government TGA Therapeutic Goods Administration

Notified Bodies

NSAI: National Standards Authority of Ireland

BSI

TUV Product Services

USA

FDA US Food and Drug Administration

CDRH Centre for Devices and Radiological Health

FDA: Consensus Standards

Policy:  http://www.fda.gov/cdrh/osel/guidance/321.html#3a5

List:      http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20939.htm

INTERNATIONAL

GHTF Global Harmonization Task Force

ISO International Organization for Standardization
 
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US Regulations

US Guidance Documents
European Regulations
 


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

Ireland

Book now to secure your place on our remaining public training courses in 2012

QS Regulation

11-12 June, Limerick, Ireland

Process Validation

13-14 June, Limerick, Ireland

Process Validation

16-17 October, Ireland

QS Regulation

23-24 October, Limerick, Ireland

United Kingdom

Book now to secure your place on our remaining public training courses in 2012 at Smithers RAPRA, Shawbury, Shropshire, UK.

QS Regulation

3 July,

Process Validation

4 July

Medical Device Design & Development

5 July

Denmark

Book now to secure your place on our remaining public training courses in 2012 at DS Certificering, Copenhagen, Denmark.

Process Validation

Dates to be confirmed soon

Medical Device Design and Development Control

Dates to be confirmed soon

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

Dates to be confirmed soon

Links & Downloads

downloads