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Quality Adherence to an effective and efficient quality management system is crucial to the success of any medical device company. Standard operating procedures and protocols ensure that control is maintained throughout the development, manufacturing and post-market life-cycle of the device. Proquamed personnel have extensive experience of successfully implementing quality management systems that are compliant with the current international standards and regulations including:
Regulatory Compliance A medical device must comply with the specific regulations for each market it will be sold into. Proquamed consultants have experience in the approvals processes and regulations for the major markets throughout the world including USA, Europe, Canada, Australia and China. Risk Management Risk Management is crucial to successful medical device development. It is a process started at product conception and continues throughout development, manufacturing, product release and product maintenance. A risk based approach to medical device development, manufacturing and maintenance is recommended and expected by regulatory approval bodies. Proquamed can implement the correct processes and procedures to ensure an effective risk based approach to development, manufacturing and ensure controlled product maintenance is adhered to throughout the life time of the medical device. Due Diligence: Regulatory compliance issues are complex and ever changing, and a non compliant company can pose serious financial risks for a new owner, partner or investor. Conducting thorough regulatory due to diligence is one of the most effective ways to reduce these risks. Proquamed can provide assistance to customers by assessing the levels of regulatory compliance for both marketed products and those in development, and produce action plans to address any shortcomings. |
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