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Authorized
Representatives For Medical Devices
- An Authorized Representative is the main contact
for the European Commission and the National Competent
Authorities.
CE
Marking Consulting - CE is the symbol
of trust and reliance amongst the customers.
Authorized
European Representative - The Authorized
Representative must be included on the product
labeling (and/or) instructions for use etc. He
becomes (from a legal standpoint) intrinsically
tied to the manufacturer.
Clinical
Trials - Clinical trial/ clinical
research can be defined as a very well defined
procedure to have an efficient feedback on whether
the treatments are effective in improving health
or not.
FDA
Consulting - The U.S. Food and Drug
Administration (FDA) is the U.S. Government agency
that oversees most foods and medical products.
Internal
Quality Audit Help - When an audit
is conducted by the people of the organization
or related to it then it is called internal audit.
ISO
13485 and ISO 9001:2000 - If an organization
has been awarded an ISO certification, it hints
that strict standards of quality are being followed
in the organization.
Regulatory
Submissions - Need to find assistance
with medical device consultants to write FDA PMA,
IDE, or 510k sumissions?
Regulatory
Consulting - Methodize Inc. is a
regulatory affairs consulting firm based in Minneapolis....
Submitting
a 510(k) Application - Methodize
Inc. leads medical device companies through the
process of submitting a 510(k) Pre-Market...
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