Your Partner for Successful Market Entry

• September 2009 News: Revised Medical Devices Directive
  Dr Jed Place presents paper on the Revised Medical Devices Directive at Medical Device Summer School and launches programme of compliance support for manufacturers to ensure they meet the requirements of the Revised Directive.
  
  
• March 2009 News: MEDTEC UK Presentation
  Dr Jed Place presents paper on Product Launch and Post Launch Assessment in Regulatory Conference at MEDTEC UK.
  
  
• December 2008 News: Coronary Catheter Assignment
  MDTc appointed to develop and implement regulatory and quality strategy for innovative coronary catheter start-up company.
  
  
• April 2008 News: In Vitro Diagnostic Device Study
  MDTc awarded regulatory strategy and market research assignment by major global medical equipment manufacturer for novel in vitro diagnostic device for home use.
  
  
• February 2008 News: ISO 9000 Certification
  Acting as part-time Quality Manager Dr Jed Place achieves ISO 9000:2001 certification for pharmaceutical instrumentation manufacturer.
  
  
• December 2007 News: Manufacturing Partner Selection
  MDTc leads team to select manufacturing partner for an electromechanical drug delivery device. Selection process covers the leading contract manufacturers in Europe and includes assessment of engineering and manufacturing capabilities.
  
  
• September 2007 News: MDTc consultants finish medical device dossier
  MDTc consultants complete major assignment for Pharma client to create medical device section of Investigational Medicinal Product Dossier for 2 major 10 country/ 40 site Phase III clinical trials in Europe.
  
  
• July 2007 News: A further new contract for MDTc
  MDTc awarded contract to produce Technical File for CE Marking a further innovative product spun out of the NHS- the third such project this year.
  
  
• March 2007 News: MDTc and a software validation project
  MDTc initiate major retrospective software validation project for pharmaceutical industry instrumentation supplier in preparation for development of fully 21 CFR 11 compliant solution.
  
  
• December 2006 News: MDTc end of year update
  MDTc completes the year with increased international activity including the provision of regulatory consultancy to clients in South Africa and Australia for new products for global markets.
  
  
• September 2006 News: MDTc involved in multiple projects
  MDTc is now actively engaged in three projects utilizing Micro/ Nano technology in the healthcare field.
  
  
• June 2006 News: MDTc forms alliance with US clinical solutions consultancy
  MDTc and Clinical Solutions International (CSI) of Vermont, USA announce a strategic alliance to work jointly on international projects for European and North American clients.
  
  
• April 2006 News: Major drug delivery device project
  MDTc appointed to take lead role in the management of the development of a drug delivery device for a speciality pharmaceutical company.
  
  
• February 2006 News: MDTc provide input to FRAS website
  MDTc provided the text for the Financial and Regulatory Advisory Service website In Vitro Diagnostic Devices pages.
  
  
• January 2006 News: Record sales and order book
  MDTc ended 2005 with turnover up 200% on the year due in large part to two major process validation projects. We go into the New Year with an expanded team to deal with a record order book.
  
  
• November 2005 News: Medica a great success for MDTc
  MDTc enjoyed another busy and successful exhibition at Medica- making a record list of contacts.
  
  
• September 2005 News: MDTc conducts a Surgeons Workshop.
  MDTc develops and conducts a Surgeons Workshop to determine the critical functional requirements for a novel intra-operative diagnostic probe on behalf of a client.
  
  
• June 2005 News: MDTc adds Clinical Trials expertise to the team.
  MDTc can now offer a range of services for clinical trials design and management by the addition of a clinical specialist to the team of Associate Consultants.
  
  
• April 2005 News: MDTc extends Validation Services.
  MDTc adds further validation engineering resources and takes on new assignments for Process and Computer Systems Validation.
  
  
• February 2005 News: MDTc achieves record start to New Year.
  MDTc follows the success of Medica with the signing of a record number of contracts across the UK. The team has been further strengthened in order to meet the needs of these new clients.
  
  
• December 2004 News: Medica exhibition a Major Success for MDTc.
  MDTc exceed all expectations by making 90 new contacts from 21 different countries. We look forward to helping many of these companies meet their medical device targets during 2005.
  
  
• November 2004 News: MDTc Launches expanded range of services at Medica.
  MDTc attend Medica, November 24-27 in Dusseldorf, Germany and launches an expanded range of services to assist companies bring medical device products to market. Under the banner "Your Partner for Successful Market Entry" MDTc promote Market Research, Product Development, Manaufacturing and Packaging in addition to the established Regulatory Affairs and Quality Systems services.
  
  
• September 2004 News: MDTc adds Market Research Expertise to Portfolio
  Chris Lamaison joins MDTc as an Associate to bring a wealth of expertise in the area of Market Research. With extensive experience in the fields of Medical Devices, Nanotechnology and MEMS Chris is available to help clients research and resolve marketing problems.