Consulting
We are aware of the drivers
that impose tight deadlines in regulatory
submissions and product approvals. Accordingly
we work with our clients to:
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Classify
their device(s) in accordance with pertinent regulations and standards.
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Agree
and Develop best-fit regulatory strategies that enable regulatory clearance
by the relevant national agencies.
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Establish
a clear Project Plan to implement the strategy and liaise with the
necessary authorities.
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Provide
practical consultancy support services that ensure the collation of data that
evidences product, system and regulatory compliance
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Complete
and submit the necessary documentation including 510k applications and
PMA's.
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Liaise
with National regulatory authorities such as MHRA, Health Canada, and the FDA.
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Complete
the necessary product and establishment registration forms.
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Provide
on-going consultancy support services that ensure product, system and regulatory
compliance.
Call
+44 (0)1292 671555 for a confidential, no obligation
discussion.
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Regulatory Affairs |
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From our
considerable experience in assisting our
Clients attain success we advise and encourage
product designers, developers and /or
manufacturers to obtain advice from
experienced RA /QA consultants at the
earliest opportunity. Timescales and
documentation requirements for approvals can
be onerous. Professional advice early will
save both time and cost.
From concept, design, manufacture to
regulatory clearance we provide the support
necessary to comply with national regulations
and standards.
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Quality Assurance |
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We design
implement and maintain systems of control to define
specifications and ensure validation of your products, processes
(including sub-contracted processes) to meet national and
international standards.
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Documentation
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Key to all
medical device design, manufacture and marketing is the
identification, collation and control of material, product,
process, labelling, post market surveillance and device
reporting documentation.
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