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QSite - Regulatory Affairs

Qsite Provides global regulatory, QA and clinical consulting services to the medical device industry.

http://www.qsitemed.com/

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QSite - Regulatory Affairs | qsitemed.com Reviews
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Qsite Provides global regulatory, QA and clinical consulting services to the medical device industry.
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1 Qsite
2 Arazi group
3 Biostatistic
4 s CE
5 Clearance
6 Clinical study
7 Consultant
8 CRA
9 FDA
10 Health authority
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about us,services,links,regulatory affairs,find out more,qa and compliance,software qa,biostatistics
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QSite - Regulatory Affairs | qsitemed.com Reviews

https://qsitemed.com

Qsite Provides global regulatory, QA and clinical consulting services to the medical device industry.

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1

QSite - Regulatory Affairs

http://www.qsitemed.com/regulatoryaff.htm

Clinical and Pre-Clinical Studies. Clinical and Pre-Clinical Studies. Qsite provides a full range of regulatory assistance and support to medical device companies. Our key services include:. Developing and Implementing Regulatory Strategies. Determine the optimal regulatory route. Preparing and Submitting Regulatory Files such as:. Investigational Device Exemption (IDE) applications. Technical files for EU marketing. Canadian device license applications. Developing and Implementing Regulatory Strategies.

2

QSite - Regulatory Affairs

http://www.qsitemed.com/software.htm

Clinical and Pre-Clinical Studies. Clinical and Pre-Clinical Studies. Software verification, validation and testing procedures and protocol, and preparation of software submission files. Key Software QA Services:. Write software design procedures per FDA and CE requirements. Meet the FDA software guidance, CE requirements, safety requirements for Programmable Electronic Medical Systems and software contained in medical devices. 510(K), IDE, and PMA software submissions for all classes of devices.

3

QSite - Regulatory Affairs

http://www.qsitemed.com/clinical.htm

Clinical and Pre-Clinical Studies. Clinical and Pre-Clinical Studies. Clinical and Pre-Clinical Studies. Protocol design and writing. Case report form (CRF) design and production. Submission to and liaison with Ethic Committees/IRB and MOHs. Preparation of Investigator Brochure (IB). Writing Inform Consent Form (ICF). Preparing all necessary site files. Writing clinical study procedures (SOP's). Site evaluation and qualification. Routine monitoring throughout the study. Database development and management.

4

QSite - Regulatory Affairs

http://www.qsitemed.com/biostatistics.htm

Clinical and Pre-Clinical Studies. Clinical and Pre-Clinical Studies. We have experienced biostatisticians and the necessary tools for clinical, pre-clinical and performance testing. Turning your product into reality.

5

QSite - Regulatory Affairs

http://www.qsitemed.com/qa.htm

Clinical and Pre-Clinical Studies. Clinical and Pre-Clinical Studies. Design, assess, and implement quality systems, procedures, and documentation to meet U.S. FDA QSR/GMP, ISO standards, European Medical Device Directives, Canadian Medical Device regulations and other medical device authorities' requirements. Implementation of quality systems, procedures. Documentation processes to meet international regulatory requirements. Corrective and preventive action programs. The European Union requires all fore...

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Qsite is a professional, experienced, consulting group focused on the medical device industry. Our services include advice on international regulatory affairs, clinical affairs, biostatistics and global Quality Assurance (QA). Our experienced team consists of experts in regulatory affairs, product manufacturing and testing, facility inspections, statistics and clinical trial design and evaluation. Our familiarity with the regulatory process will help you to bring your product to the market.

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