GMP/QSR Compliant Quality Systems Design, Implementation and Maintenance
The success of a medical device company depends in part upon its quality management system to be nimble yet conforming to QSR/GMP, ISO 13485 and other applicable regulatory requirements. Quality Assurance procedures following best practices ensure safety, maintain product quality and ensure adherence to requirements. Start-ups as well as mature companies benefit from Smestad & Associates and our expertise in designing, implementing and maintaining quality and compliance systems. The following are some of the services we provide in this area:
- Develop and implement strategies to ensure compliance with regulatory requirements and government regulations
- Conduct gap assessments and resolve compliance issues
- Develop and implement corrective and preventive strategies
- Use information gathered through interviews with company personnel to design agile, compliant quality system processes using best practices
- Design and implement sound quality management systems based on Quality System Regulations (QSR) and ISO 13485
- Conduct audits of suppliers, quality system processes and Good Laboratory Practice (GLP)
- Deliver QSR/GMP/ISO 13485 training
- Develop Corrective Action and Preventive Action (CAPA) and complaint handling systems