Medicom Consulting

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Can you work with our team on site for short and long periods of time?

Yes, we provide both on-site and off-site assistance for projects, according to your needs.  We maximise use of web based communications such as VPN to provide all deliverables agreed between us.

 

Do you have the expertise to meet our needs?

In the majority of situations the answer is yes, we can call upon Medicom’s resources to deliver the solution required, however if we believe we do not have the expertise or resources we will tell you, and attempt to identify where such resources can be obtained. 
We have a broad network of industry, consultancy and regulatory contacts throughout Europe and the US, that can be called upon to meet your needs.

 

Do you provide mentoring?

Yes, we have provided mentoring on a one-2-one, and team basis, in a variety of activities. A mentor can bring an outside and fresh perspective to the issues and aid in the decision process. They also bring clarity and help you focus on the issues that matter to assist you reaching your potential.

 

What Languages do you work with?

English is the primary language for all business communication, however, some of our personnel are fluent in German, Dutch, Danish, and French which makes certain activities easier e.g. training.

 

Can you provide temporary cover?

Yes, we can provide on-site temporary cover where additional resource is required.  For example, in the preparation of regulatory submissions and responses to authorities; pre-audit preparation; holiday, sick cover and maternity leave.

 

Can you project manage, are you happy to work with other sub-contact project managers with input from our team?

Yes, we are excellent project managers, and have our own project management experts if needed, moreover we have proven success in working within project management teams.

 

Can you provide us with training specific to our company?

Yes, we are happy to discuss your needs and tailor appropriate training for all levels of personnel at your company.

 

How much notice do you need to start a project?

Good question, like all businesses our resources are not limitless, however we will be able to answer honestly within the first day or so of contact with us. If the matter is critical we can start within days providing we have sufficient resources., e.g. FDA Warning Letter responses

 

How can we track the work as it is being completed?

As part of our proposal describing how we deliver the service, we set up a Medicom Project Manager and a Client Project Owner, the proposal contains the mechanism for routine reporting requirements and notification of any major problems, between these individuals. We have never had any complaints on timeliness of delivery.

 

Can you provide us with ad-hoc advice if we have urgent questions?

Yes, we do this on a regular basis for our existing clients, in many instances where this is not particularly time consuming for us, no fee is charged.

 

Will our information and problems remain confidential?

Yes ………… absolutely, we sign non-disclosure agreements/confidentiality agreements with all of our clients and consultants which protects all of our discussions and documents provided to us.

 

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

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