US:
Steps to Market
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Summary |
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STEP 1:
Confirm your Device is a
Medical Device
STEP 2: Define the
device Indications for Use &
Performance Claims
STEP 3:
Establish Regulatory
Classification & Product
Code
STEP 4:
Select the Type of
Pre-Market Submission
Required
STEP 5:
Prepare development plan to
include regulatory
requirements.
STEP 6:
Define who does what: Contract
Out?
STEP 7:
Document and implement systems
of control (See ISO 13485:2003
and CFR 820
STEP 8:
Develop
Technical Agreements with
Suppliers / Contractors.
STEP 9: Collate
evidence of of meeting
Indications for Use and
Performance Claims
including Predicate
Comparison
STEP 10:
Complete
Regulatory
Application
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Call George Buchan on +44 (0)1292 671555
for a confidential, no obligation
discussion.
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ISO / US Standards |
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Identifying
and providing support to ensure compliance with US / ISO
Standards for Medical
Device / Software design, manufacture, packaging,
sterilisation and labelling and post market surveillance.
See US Database of Recognized Standards
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Regulatory |
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Defining and ensuring
documentary evidence of compliance with Design History Files and Device Master Records
as specified in FDA 21 CFR 820 US Regulation.
Preparing regulatory submissions to the FDA
e.g. 510k or PMA
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QS Documentation |
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Hands on
support to design and implement management
systems including: ISO13485:2003 and CFR820.
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