To maximize the benefits of our services, we would ideally work with
medical device companies who manufacture and design Class I and Class
II medical devices and independent testing laboratories who wish to
utilize our 601 expertise on a contract basis.
In addition, to minimize associated expenses, most of our services can
be performed remotely via email, telephone and WebEx.
We offer a wide range of services that will fit your budget and
milestones:
WebEx Seminar &
Training:
Customized training or seminar based on your level of experience with
60601 series standards this can be offered on an individual basis or as
a group.
Pre-Compliance Review on
Prototypes:
Ideal for early and pre-certification compliance review. We can assess
your current design against 60601 2nd and 60601 3rd editions. At the
end of our review, you will receive a comprehensive report detailing
the non-comformances. But, we don't stop there...we will also provide
cost-effective compliance design recommendations to meet the applicable
60601 requirements.
Coordinate Formal
Certification with Agencies:
We have established a strong relationship with major Nationally
Recognized Testing Laboratories (NRTLs) and Notified Bodies that can
work to your advantage in terms of potential compliance cost reduction
and expedited certification services. In additon, our prior experience
working directly with major Agencies will provide inside know-how on
their processes. We can assemble the relevant documentation needed to
efficiently certify your products and expediently coordinate the whole
certification process with your chosen agency.
Risk Management File Review
(RMF):
There are approximately 85 references from 60601 3rd edition that point
to your product RMF. We can assess the documentation GAPs and provide
recommendations on document creation and process generation in
accordance with ISO 14971.
Provide Compliance Design
Inputs on New Product Development:
It is important that 60601 requirements are integrated as early as
possible throughout product development. The idea is, once it's all
said and done, is to have a compliant product prior to submitting for
certification. We can work directly with your design teams and provide
inputs from 60601.
IEC 60601 2nd and IEC 60601
3rd GAP Analysis on Legacy Products:
Not all countries or regions will require mandatory compliance to the
IEC 60601 3rd edition come June 1, 2012 so it is recommended that your
products are designed to the worst-case requirements from both 60601
2nd and 3rd editions and have dual certifications. Questions such as,
will a 60601 2nd edition certified power supply be acceptable for 60601
3rd edition under the CB Scheme? Will the power supply be acceptable
for home healthcare use? We can assist in "critical" component
selection and work with your supplier to identify requirements that
meet both 60601 2nd and 3rd editions.
Risk Analyses:
Assit with FTA, FMEA, DFMECA, and other risk analysis tools to address
risks called-out in 60601 3rd edition.
