Case Study: Megadyne Medical Products achieves multi-agency regulatory compliance and faster change control with MasterControl

Consolidation Helps Megadyne Medical Products Successfully Comply With Multiple Regulatory Agencies

Megadyne Medical Products, a manufacturer of electrosurgical devices used in 72 countries, faced mounting compliance and operational challenges from maintaining a paper-based quality system. Meeting multiple regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU, Canada, Japan) meant slow, serial routing of change orders, lost documentation, heavy administrative overhead and difficult, time-consuming audits.

In July 2014 Megadyne implemented MasterControl modules for Change Control, Training and Complaints, hosted on their on‑premise virtual environment and administered by a non‑technical document control lead. The system automated parallel routing and approvals, centralized training records, eliminated lost change packets, reduced complaint-handling staff and cut review cycles from months to days—resulting in smoother audits, fewer findings, better traceability and more time to focus on product development.

Megadyne

Haven McCall

Vice President of Quality and Regulatory Affairs