Medical Device Single Audit Program (MDSAP)

Date: January 24, 2019

Location: Holiday Inn, Marlborough, MA

Dinner Meeting Agenda:

6:00-6:30 PM – Networking

6:30-7:15 PM – Dinner

7:15-7:30 PM – Section Business

7:30-8:30 PM – Dinner Presentation

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements.

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the United States. The program’s main mission is to “jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”

Presenter: Orpha James

Orpha James has thirty years of experience in medical device companies, has designed catheters to withstand e-beam and gamma sterilization processes, designed thermoplastics Elastomers for medical, as well as industrial use such as shoe soles, wire and cable, TPE, TPRs, EPDM, and PVC for extrusion profiles. She has also worked on medical devices, such as Insulin pumps, O-Arms, and Defibrillators.

She is an expert in Medical V&V work while using an analytical approach to problem solving, as well as an expert in Project Management, CAPA, SCAR, NCR, Score Card, Risk Assessment, Sterilization, Supplier Management, Root Cause Analysis using quality tools 8D, 5 Whys, Biocompatibility, Cost Savings, and efficiency in the plastics fabrication, electronics, and metal industries.  At present, working as a Lead Auditor for a Notified Body.


MS in Plastics Engineering, MS Biotechnology, BS in Chemistry, BS in Teaching. Published the following papers in scientific journals.


  • Determining the Biocompatibility of Nanomaterials
  • Electron Beam Compatible Polymers
  • Recycling of thermoset Flexible Polyurethane Foams into Solid Polyurethane Rubber
  • Color, Colorants & Color Measurements