Medical Device Quality
Advances in medicine and medical research have extended and enhanced the lives of countless individuals around the world. These advances have brought with them increased complexity as well as increased risk. Medical device manufacturers have strict regulations to which they must adhere, pressures from consumer advocate groups and high degree of legal responsibility, all of which demand not only due care, but advanced analysis of proposed designs and processes. Quality Associates has the experience and knowledge to:
- Educate on the various APQP - Advanced Product Quality Planning tools, and demonstrate the best practice application of these tools.
- Improve Product Development process and activities to assure fast but efficient product inputs and outputs.
- New Product Introduction (NPI)
- APQP and Collaborative Product and Process Design (CPPD)
- Identify Risks and provide risk mitigation process discipline.
- Identify areas for increased controls for manufacturing
- Improve documentation and warnings for patients and caregivers.
- Product Liability
- Increase security of stocks of valuable materials to be used in manufacturing the drug or device.
- Supplemental testing based on robust design factors not written in standards and SOP’s.
- Robust Analysis
- Setup training for operators in compliance with FDA expectations
- Improve or assure conformance to regulations
- Document and improve Good Manufacturing Practices (GMP) procedures and work instructions.
- Assure compliance to ISO 9001:2000 when applicable.
- Conduct studies on efficacy and reliability.
Need more information?For more detailed information on this topic please email our qualified staff , contact us by phone at (248) 280-4800, or fill out our Contact Form.