Additional Information
Implementing Reliability Program Plan
-Develop Organizational Reliability Goals
-Concept stage
-Design Stage
-Product Development Phase
-Assurance Stage
-Manufacturing &Launch Stage
-Product Surveillance Phase
Regulatory Support
-Regulatory Gap Analyses
-Premarket Submissions and Process remarket Notification (510k)
-510(k) Submission Methods and Process
-Verify compliance of design requirements and procedures FDA Class 1, Class II and III device testing and regulatory consulting –
Post Market Surveillance and Vigilance Reporting
-Implement Device Tracking Program
-Investigated and maintained complaint files in compliance with regulations established by the FDA as well as other international regulatory bodies
-Training program and offering performance evaluations; utilize creative techniques to guide and train to employees on current MDR regulations, MDR guidelines, MDR interpretations, product labeling, other federal laws
Device Analysis Laboratory
-Test method development and validation
-Failure analysis
-Analytical techniques including but not limited to:
-SEM
-High Power Microscopic
-EDS
-WDS
-FTIR
-Mechanical testing
-HPLC
-UV VIS, ELISA
Medical Distribution in East and West Africa
-REMARQ-MED offers medical related products and biomedical distribution solutions for both medical product manufacturers seeking to establish or expand their product into the global healthcare community and medical product distributors seeking quality medical products.
-Distributor medical related products and biomedical equipment
-Rentals and service into the alternate care market