Medical Device Consulting at ITL Group
ITL Group offers a range of medical device consulting services to support you through every stage of your product development lifecycle. We offer consultancy for product development projects and regulatory affairs consultancy.
Our engineers can act as consultants for the following aspects of your medical device project:
Funding and grant application support
ITL have experience in helping our clients to access the various government grants and other funding sources available by providing planning and budgetary information.
In the past we have supported clients in successful applications for TSB (Technology Strategy Board) grants and even building early-prototypes for funding campaigns.
Project status reports
Are you completely sure that your development project is on target to meet your plan? If not, our engineering consultancy services will help you to take a holistic look at your project and identify any areas that may need attention.
Full technical file audit
ITL Group’s multidisciplinary engineers can conduct technical audits of all aspects of your technical file including regulatory considerations, software documentation, risk assessment and give you suggestions as to anything that is missing, incomplete or incorrect.
Manufacturing package audit
As a medical device manufacturer we know exactly what your manufacturing package should include. Our production engineers are able to provide an audit of your manufacturing package to ensure that you have all of the necessary documentation required to transfer your product in to manufacturing.
We can also provide guidance on design for manufacture and design for commercialisation.
Our medical device regulatory affairs consultancy services include
Regulatory compliance assessment
Our regulatory affairs team can help with pre-compliance safety and regulatory assessments to assist you in considering your medical device product development project.
We are well-versed in all of the regulatory requirements for medical devices sold in European, American and other worldwide markets and can ensure that both your documentation and your device itself meet these requirements.
CE marking, US FDA and China CFDA regulatory accreditations
If your project is already in progress we can also help you to achieve accreditations such as CE marking, FDA (American Food and Drugs Administration) and CFDA (Chinese Food and Drugs Administration) accreditation.
Investment due diligence
If you are considering a merger, acquisition, investment or a new venture ITL can provide a detailed, unbiased assessment of the risks and benefits
Read about our medical device development and design project with Endomag