MEDICAL
DEVICE PRECLINICAL AND CLINICAL TRIAL PROJECT MANAGEMENT
Before you go to China
for SFDA approval, you will begin to conduct pre-clinical
tests and clinical trials and collect appropriate data
to support your study endpoints. Airtrust can help you
to ensure that the appropriate testing is conducted
and that your study data is presented in the most appropriate
formats for the regulatory agencies and others who will
pass judgment on your new product.
Throughout the course
of your medical device clinical study, Airtrust project
managers will oversee day-to-day study activities, giving
you confidence that all the relevant data are captured,
collected, and interpreted to support your study goals.
Your project manager will assist the clinical sites
with submissions to the appropriate Institutional Review
Boards, Ethics Committees, and regulatory bodies to
facilitate the approval process, provide routine reporting
on study progress to keep you apprised of data accrual
and data quality on a site-by-site basis, and keep you
and your study team on track with regular communication.
We will work with you to:
- Define appropriate pre-clinical and
bench studies
- Develop a clinical trial design,
prepare study protocols and study documents
- Identify study sites
- Obtain Regulatory Committee Approvals
- Collect, manage, and monitor clinical
trial data
- Perform statistical analysis
- Prepare clinical study report
- Further design and implement your
quality system to meet SFDA requirements.
MEDICAL DEVICE
REGULATORY CLEARANCE / APPROVAL
In order to gain medical
device regulatory clearance or approval, you will need
to meet specific criteria set forth by all of the appropriate
regulatory bodies. You will also need to preserve the
integrity of your manufacturing process as you scale
up for production. Airtrust can prepare you and your
facilities for possible regulatory audits, including
SFDA inspections and registrar or Notified Body assessments.
POSTMARKET MEDICAL
DEVICE ACTIVITIES
You have successfully
entered the marketplace, but conditions are constantly
changing and your ability to maintain product viability
is regularly challenged. Perhaps you are planning to
expand your marketing, introduce enhancements or changes
to your device, its labeling or instructions. You may
be concerned about successfully managing your post market
surveillance efforts. Airtrust can help you to plan
and manage all of these challenges. Our consultants
have the knowledge and expertise necessary to help you
to:
- Develop effective and competitive
regulatory strategies to address future product
and labeling changes
- Prepare Traditional or Special for
new devices or existing device modifications
- Design, manage, and monitor any clinical
studies you may need to support future submissions
or to meet any post-market requirements
- Prepare your team for SFDA inspections
and registrar or Notified Body assessments
- Manage your post-marketing surveillance
requirements, include complaint handling, medical
device reporting, vigilance reporting, failure investigations,
problem reporting and device tracking
ONGOING POSTMARKET
COMPLIANCE
If quality assurance problems
do arise once your medical device has entered the market,
Airtrust will work with you to respond quickly and re-establish
compliance. To help maintain post market compliance
for your medical device, we will:
- Develop appropriate enforcement action
responses and/or corrective action plans in response
to SFDA and warning letters
- Develop effective product recall
strategies, including notification to applicable
regulatory agencies and customers
- Assist with post market surveillance
to address complaint handling, failure investigation,
problem reporting, and device tracking
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