Empowering excellence in quality management for enduring success.

We help organizations implement robust Quality Management Systems tailored to their unique needs, fostering a culture of quality, continuous improvement, and customer satisfaction. Our quality management services include:

• QMS Implementation: Developing and implementing customized Quality Management Systems.

• Quality Audits: Conducting internal and supplier audits to assess compliance and identify improvement opportunities.

• CAPA Management: Establishing and managing Corrective and Preventive Action programs.

• Quality Metrics and Reporting: Developing and analyzing key quality metrics to drive improvement initiatives.

Areas of expertise:

• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

• 21 CFR Part 820: FDA Quality System Regulation & Quality Management System Regulation (QMSR)

• 21 CFR Part 11: Electronic Records and Electronic Signatures

• EU Medical Device Regulation (MDR) 2017/745

• EU In Vitro Diagnostic Regulation (IVDR) 2017/746

• MDSAP: Medical Device Single Audit Program