Kavitha Rajaram, Senior Software Development Analyst, Pilgrim Quality Solutions, an IQVIA company
With deadlines approaching, ISO 13485 compliance is becoming more critical than ever before. Additionally, since ISO 13485 will be used as an auditing standard for the Medical Device Single Audit Program (MDSAP), your company may need to adhere to these standards during a regulatory audit. If you haven’t signed up for MDSAP audits yet, to prepare, you should conduct a gap analysis that closely examines organizational processes, especially quality management.
One of the prime high-risk areas in any manufacturing enterprise is its supply chain. A solid Supplier Quality Management system will support the processes that enhance supplier quality and keep supplier risk under control, improving the enterprise’s overall quality and compliance. (more…)