Preparation and review of regulatory
submissions |
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Submit regulatory
submissions (510(k) notifications,
European CE Mark, Canadian CMDR,
Australian TGA Class III and Conformity
Assessment |
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Complete US FDA registrations
and listings |
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European CE marking dossier preparation
and review |
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Prepare new product
regulatory and quality system
documentation to support Australian
and international assigned projects
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Technical dossier reviews |
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Prepare Design Dossiers and Technical
Files for medical devices |
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Implement integrated ISO 13485
and FDA quality system requirements
(QSR) |
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Characterize design control regulatory
requirements for Australian and international
markets |
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Regulatory advice and consulting support
for post market requirements |
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Process and Systems reviews |
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Technical Reviews |
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Strategic Planning for Australian and
international regulatory and quality
system requirements |
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Internal quality system audits |
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Gap analysis for ISO 13485 and
Medicine GMP |
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Supplier due diligence and assessment
audits |
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| Product
labelling reviews |
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| Advertising
Promotional Materials reviews |
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| Training
in Medical Device and IVD regulations,
FDA QSR, ISO 13485, Medicine GMP, internal
auditors |
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Contact us to find out how we can tailor
our services to fit your regulatory and
quality needs.
