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Compliance
Approvals
AuthRep-USAgent
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The CRO Group specializes in compliance and approval regulatory support services for
the biotech, IVD, and medical device industries.
- Quality Systems
- Our services range from establishing a fully documented quality
system such as that required for FDA/QSR, CE
Marking, or Canada, to managing projects to prepare for
quality system upgrades to the ISO 13485:2003 standard, to individual project
contributions for specific projects such as installation, operation, and
performance qualifications / validations for automated manufacturing equipment
and serving as your internal quality auditors..
- Product Clearances,
Approvals, Licensing
- Has the FDA classified your
product? Over 30% of devices have different classifications according to
USA/FDA, European, Canadian and Asia/Pacific Rim regulations. Is
there a FDA guidance or European Common Technical Specification applicable to
your product? How many times will your device be tested? One, if you
choose The CRO Group to assess your product for compliance with the applicable
standards. Our expertise includes EMC, electrical safety, programmable system
/ software safety, risk analysis, labeling, microbiology, and biocompatibility, and preparing
510(k)s and PMAs as well as technical files and design dossiers for CE Marking.
- Clinical Investigations
- Which countries have
mandatory clinical study requirements as a prerequisite for product licenses?
How
can we clinically study our device once and use the results for USA and Europe? These are just
some of the questions we address with our Regulatory Management service.
- Regional Market Access
- Is your goal CE Marking?
Do you have an office in the EU? If not, you may be
interested in our
Authorised Representative
service. Have you registered your device
with Health Canada? Are you located outside the
USA and wish to market your products within the USA? If so, you may be
interested in our U.S. Agent service. Tell us what your international sales
expectations are or where you want
to go with your products. We will help you get your
products there, affordably..
- Other Services
- Acquisition/Spin-off
Due Diligence Audits, Part 11/Electronic Signature/Records
Audits and Remediation are some examples of our other services.
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