First MDSAP Alum Gives Single Audit Process High Marks; Challenge Was Brazilian, Aussie Regs
Manufacturers planning to participate in the Medical Device Single Audit Program should first study up on Australian and Brazilian regulations, an official at the first company to go through a MDSAP audit tells IDDM.
James Hamer, global director of quality and regulatory affairs at Arthrex, says the company became interested in the International Medical Device Regulators Forum’s two-year MDSAP pilot program after participating in a U.S. FDA pilot program. The North Naples, Fla., manufacturer of orthopedic surgical supplies was able to defer routine FDA audits by annually submitting ISO audit results to the agency.
“We saw this as a huge benefit in that … audits and inspections can be a huge resource drain,” Hamer explains. When company officials heard about the MDSAP audits, which would allow Arthrex to similarly “set aside” audits by Brazil, Canada, Australia and Japan, it was easy to opt for the audit and obtain management buy-in, he says.
Making the choice to participate was easy, but scheduling the audit posed a hurdle, Hamer says. When the company decided to participate in MDSAP in late July 2014, it already had an ISO audit scheduled for September. Auditor BSI worked with the FDA and Health Canada to coordinate the timing and contractual details, and the audit took place from Sept. 22-26, 2014, with four BSI inspectors and U.S. and Canadian regulatory observers.
The MDSAP auditors’ approach followed the FDA’s Quality Systems Inspection Technique model more closely than a standard notified body approach, Hamer says. But the audit touched all areas of 21 CFR 820, ISO 13485 and additional Brazilian and Australian regulatory requirements. The most striking difference from an FDA audit was that, in Hamer’s experience, FDA investigators tend to look to complaints as a basis for further investigation, while the MDSAP team balanced complaints, CAPA and nonconformances.
The largest surprise during the audit was questions on fine details of Australian and Brazilian regulations, Hamer says. “The MDSAP audit team was understanding in how they could have gone unnoticed,” he relates, “but still wrote nonconformities.”
The company will stick with MDSAP audits in the future, Hamer says.
Arthrex and other devicemakers that have gone through MDSAP audits will be able to share their experiences during a June 23 IMDRF meeting set to coincide with the midpoint of the pilot program (IDDM, March 20). — Elizabeth Orr