I don't think I have ever read through so many Elsmar Cove posts on any one subject that I am so much involved with.
I just want to start with this one point. Whatever you may think about the company in question, the FDA has cleared all of their products and allows them to be legally marketed.
For my part, I led the development of the new IAF program of accreditation for ISO 13485. It was based on the combined input of four highly respected notified bodies, input from the IAF member Accreditation Bodies, and we included regulators, including a top expert in Quality Systems from the US FDA, Switzerland and a visit from another in Germany. The IAF Accreditation structure was intended to take the existing handbook used for Notified Bodies, the International Accreditation framework of IAF (ISO 17011 and ISO 17021 and several IAF MDs) and look at what Health Canada's required of SCC accreditation assessors, witness assessments, etc, and finally, aligned the system into 5 main areas, based from a modified use of an NBOG coding structure. All of this was just intended to capture the current state of regulatory audits worldwide, but enhance the criteria so that we could reduce the vagaries that the regulators had left in place that we knew created disparities in performance among the auditors.
The IAF initiative for ISO 13485 began getting integrated when it went into effect July 2012. I received numerous reports that CMDCAS and CE notified body audits were suddenly being challenged, since the IAF requirements were NOT vague on competency and impartiality, and some of the regulatory auditors had to be replaced. This was a welcome side-effect. We were making regulatory audits better that we had no legal responsibility for.
To be honest, the requirements have challenged the entire chain of accreditation, and since it is now a worldwide program (wherever ISO 13485 certificates are issued, under an IAF member accreditation body), the ABs and CABs have been playing catch-up.
With regard to MDSAP, which intends to use Regulatory Authorities in place of Accreditation Bodies, this is a very difficult challenge for the regulators. In fact, Health Canada has never done an accreditation assessment. Those have always been performed by SCC, and in accordance with ISO 17021. Accreditation Assessors are of course well versed in operating under ISO 17011 and performing assessments against ISO 17021. Now they are having to add MD8 and MD9. Competencies related to medical devices, risk management, etc are required and audit durations properly reflect the longstanding state of the regulatory audits that have existed (we did not lengthen or shorten the audit durations that medical device manufacturers normally endure)
I want to leave this post regarding the IAF program, and put on my own hat, as a Regulator Q/RA professional, and partake in some of those other highly relevant discussions.