Summary:
OMEDtech provides the bridge between product concept and product commercialization. OMEDtech helps companies with regulatory strategies, product design, quality system development and operation, clinical trials, pilot manufacturing in an ISO 13485 certified facility and creation and submission of 510k, PMAs and CE mark technical dossiers. We are able to assist young companies by creating a flexible relationship that focuses on working with client companies' funding limitations and while meeting
Full Description:
OMEDtech meets the challenges of new product approvals, identifying and correcting regulatory deficiencies, improving operational systems and filling the gap when resources are limited and schedules are unrelenting. A few areas of expertise include:
· IDE (Investigational Device Exemption) and HDE (Humanitarian Device Exemption) Submissions
· PMA (PreMarket Approval:) Applications and 51 OK Notifications
· Clinical Trial Development and Management,
· Quality System Implementation
· Manufacturing Process Development and Management
· Quality System Reviews,
· Engine
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