I just got an email from Health Canada notifying me that they are transitioning from the ISO 13485/CMDCAS to the MDSAP certification program. ...I guess we'll have to get on board... So I've got several questions: 1. Can we leverage our present ISO 13485/CMDCAS certification? ...or must we go through a new round of certification from scratch (and incur all the costs entailed)? 2. The US FDA is apparently on-board with the MDSAP program. Does this mean no more QMS/QSR inspections from the FDA? 3. The EU is not mentioned as recognizing MDSAP. Does this mean that, moving forward, we'll have to hold 2 separate quality system certifications (EN ISO 13485 for the EU, and MDSAP for US, Canada, Australia, etc.)? If so, isn't this setup essentially doubling the QMS certification cost for manufacturers that want to sell in both North-American & European markets?