Medicom Consulting

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Welcome to Medicom Consulting PDF Print E-mail

Medicom Consulting provides professional support in quality and regulatory affairs management to the Medical Device, Diagnostic, Biological, and Pharmaceutical Industry. Our support services are designed to help companies to improve compliance levels with US, EU and other national regulations, thereby improving product quality, safety and effectiveness, and avoiding difficult financial and reputational problems associated with adverse regulatory inspections.

Our goal is to assist you attain operational excellence.

Since Medicom Consulting was established in 1995, by Tom Donnelly and Ron Pagan the partnership along with carefully selected associates, has allowed a full range of support services to be provided to more than 150 companies internationally. Our success allows us to enjoy repeat business from our client base, coupled with strong referral recommendations due to our reliable and accurate service provision.


Latest News

Regulatory Updates

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


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


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 2012 & 2013 with Smithers Rapra to provide bespoke training for medical device polymer suppliers

DS Certificering A/S partners with Medicom
Medicom successfully renews contract for 2012 & 2013 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 public training courses in 2015

QS Regulation

Process Validation

Design and Deveopement Control

CAPA and Root Cause Analysis

ISO 13485 2015 & MDD Revision

dates to be advised





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