Quality Assurance
Medpoint’s global team has experience developing and optimizing quality systems that comply with ISO 13485:2016, 21 CFR 820, EU MDR, EU IVDR, MDSAP, and more.
Global Quality Management Solutions
Medpoint’s global team has experience developing and optimizing quality systems that comply with ISO 13485:2016, 21 CFR 820, EU MDR, EU IVDR, MDSAP, and more. With certified and seasoned auditors to provide on-site and remote audits, our team can identify and correct potential compliance issues before you get audited. We offer quality system audits, gap assessments against emerging standards and regulations, and remediation activities. We also provide expertise in other critical areas, including CAPA (Corrective and Preventive Action), complaint handling, risk management, and design and development changes. Medpoint can help you create a culture of excellence and continuous improvement by meeting and exceeding industry standards.
Onsite and Remote Audits
We conduct onsite and remote audits of various types including supplier audits, internal audits, mock FDA inspections and process audits. We help our clients to identify and eliminate risk from their supply chains, and to establish and maintain compliance with regulations and standards.
Gap Analysis and Remediation
Our comprehensive Gap Assessments evaluate processes and identify areas for improvement. We also train clients in regulations and standards. By taking a proactive approach, our clients avoid potential compliance issues and associated penalties, and gain valuable insights into how to improve efficiency and effectiveness.
Contact Us Today
Contact us today to discuss your needs and discover the difference our world-class expertise will make for your business.
