ISO
9001: Does this make sense for you?
In order to move beyond regulatory requirements....
Also
consider in-house training to the new
requirements as well as internal auditing to the
Process Approach..
Contact
us for a details on training options that will fit your
needs and budget. |
|
ISO
13485: A must for USA, Canada, EU, Japan and Beyond
Gap
analyis, Internal audits, supplier audits, construction
of QMS, support for any given process with the QMS.
Also
consider in-house training to the new
requirements as well as internal
auditing to the Process Approach..
Contact
us for a details |
|
ISO
14971:2007
Risk management, now mandated by ISO 13485,
this standard has undergone significant revisions since the
"early days" of risk analysis...
Also
consider in-house training to the new requirements
of ISO 14971:2000.
Contact
us for a details |
Training:
We offer high quality and cost-effective
in-house training to:
ISO 13485 Requirements
Internal
Auditing to ISO 13485 and the Process Approach
ISO 14971:2007and regulatory requirements for Risk
Management
Contact
us for
a details |
|
FDA
Regulatory Compliance, 510k and QSR: Save
time and money by using experts.. |
|
European
CE Marking of Medical Devices:
Notified bodies, audit findings,
coping and succeeding... |
International
Supplier Quality:
One of the 8 quality principles: Mutually
beneficial supplier relationships. We can help with your supplier
program, resource needs and supplier quality issues...We get
the audits done effectively, on time and at a cost that makes
sense. |
|
Japan,
Asia and Beyond: Let us help open those
gates.. |
|
CAPA,
Vigilance and Adverse Event Reporting: A
high profile item with regulatory authorities.. |
