Whether you are subject to the regulatory requirements for Medical Devices and need to comply with the Quality System Regulations and ISO13485, or whether you voluntarily implemented an ISO9001 system to generate efficiencies and improve customer experience, implementing a best-in-class Audit program is key to your Quality operations. Is your Audit program up to the task?
Although the Europeans have retained risk classifications and 3rd party conformity assessment based on risk class, the new MDR changes almost everything. In more than ten times as many words as the MDD and AIMD, the new regulations provide much more detailed requirements and set a higher bar especially in clinical evidence, postmarket monitoring and risk management, integrating all of these into a single living process. The race is on for the three year transition period – it’s going to get busy…
At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the MDSAP audit program will combine to create a Perfect Storm which will challenge their resources of Regulatory agencies and assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm. Are you ready?
As regulations tighten – regulators get busier and backlogs and delays are increasing. In this environment, a single audit program not only reduces audit workload – it can offer speedier market access.
It’s here: the long awaited 2016 update to ISO 13485 was published at the end of February. This revision is a big shake up of the venerable devices quality standard. It’s going to need time, effort and planning for transition to the 2016 edition.
In conjunction with AusMedtech 2016 conference in Adelaide in May and leading Notified Body TUV Sud, we are hosting a full day workshop on Transition to ISO 13485:2016. It’s on 9 May, immediately before AusMedtech 2016 and there are discount rates for attendance at both events.
Just in case you missed it – the long awaited 2016 update to ISO 13485 was published at the end of February. This revision is a big shake up of the venerable devices quality standard. It’s going to need time, effort and planning for transition to the 2016 edition. Join us in Adelaide for an intensive workshop on how to make the change.