Quality Management System Counseling
AcmeBiotechs Consulting Inc. provides services on counseling Quality Management System (QMS). We help our clients meet the regulatory standards for medical device quality systems. Unlike other industries, medical device and IVD industries have more rigorous criteria for quality, safety, and effectiveness. During premarket reviews by different administrations, the quality system of companies and their products are audited closely to ensure safety and effectiveness of the device. A good quality system is essential for a medical device to enter any market. Even though the considerations for safety and effectiveness are the same worldwide, each country and region have slight differences in their standards. We help our clients recognize the appropriate strategy for developing a QMS while considering the budget of the clients. Shown below are our services for QMS Counseling.
- ISO 13485:2016
- Good Manufacturing Practice (GMP)
- Quality System Record (QSR)
- CNS 15013