Supply Chain Management and Product Quality

Increasingly complex medical devices rely on widely dispersed supply chains for ingredients, components, packaging, distribution and storage.  At each step, the manufacturer of the finished product faces quality and compliance risks from these same suppliers that they rely on. Highly publicized recalls and plans by regulators to dramatically increase global inspections have intensified those risks.

Kaplan EduNeering helps medical device companies minimize quality and compliance risks throughout their supply chains.   Our supply chain management solutions provide a combination of learning, communications, documentation and management resources for medical device companies and their dispersed supply chains. 

We are the exclusive online training partner of AdvaMed.  We also maintain a unique partnership, which gives our clients access to the same technologies and curricula used by FDA to train inspectors around the world. 

Kaplan Eduneering’s medical device solutions help companies meet compliance needs throughout their supply chains including:

• cGMPs, QSR, QSIT (US FDA);
• Medical Devices Directive (European Union);
• ISO 14971-2009 (International);
• ICH Q8, Q9, Q10 (International);
• Corporate Code of Conduct;
• Ethics;
• Foreign Corrupt Practices Act;
• UK’s Anti-Bribery Act;
• Corporate Responsibility;
• Validation and recordkeeping.