Upgrading to ISO 13485 : 2016? Full Day Intensive Training

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Full Day Intensive Training Course  : 9 May 2016 – Adelaide
In Conjunction with AusMedtech Annual Conference

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.

So what’s changing? Lots, including:

  • Much more emphasis on risk management  throughout the standard. (afficionados of IEC 60601 may find this familiar)
  • More flexibility to omit compliance to specific clauses if they are truly not applicable to your operations
  • Closer alignment to GHTF and IMDRF definitions and classifications and inclusion of more concepts and requirements from the US FDA Quality Systems Regulations (21 CFR 820)
  • Moving away from ISO 9001 (which has a new and different clause structure) and with regulatory compliance taking centre stage in ISO 13485.  Those running combined 13485/9001 systems are going to find thing more complicated and onerous.
  • More explicit links to regulatory requirements and compliance, including things like postmarket reporting.
  • New and Strengthened Technical Content in areas of verification and validation, design processes, sterilization, software validation and more.

 


Your Expert Presenter: Yasushi Murayama

Yasushi Yasushi Murayama Expert Presenter ISO 13485 TUV Sud Academy Brandwood Biomedical Global Medical Device and IVD Regulatory ServicesMurayama is a leading international expert on ISO 13485,  As an expert member of ISO TC 210 he has played an integral part in the development of the 2016 edition of ISO 13485.

Mr. Murayama is Head of the TUV Sud Academy.  He is an accredited Notified Body & QMS Lead Auditor for TÜV SÜD Japan with decades of experience of implementation and auditing.

He is an engaging and experienced trainer who conducts more than 80 training sessions annually including quality, safety, usability, risk management aFull Day Intensive Training TUV SUD Brandwood Biomedical Global Medical Device and IVD Regulatory Servicesnd regulatory requirements for medical devices manufacturers and QMS auditors


Full day registration includes lunch and refreshments and is at the
bargain rate of $500/$550 for AusBiotech Member/Non Member

or only $300/$350 if registered in conjunction with AusMedtech conference.

Click Here to Register for the ISO 13485 Workshop

Click Here for Combined AusMedtech and Workshop Registration

Want a preview? As a taster for what’s in store, we hosted a recent
Webinar on whats new in ISO13485 : 2016.  
Check out the recording  ♦  Download the slides ♦ View our other training videos.


Help button-Quick Call-Brandwood BiomedicalNeed a new quality system or has your old system gotten too cumbersome? We specialise in setting up or refreshing quality systems.  We believe in systems that reflect practice and not the other way round.  You will find no cookie cutter systems here.  Instead we prefer management systems that are light touch, appropriate to the operation and easy to manage.

Talk to us today to learn how we can help you achieve a compliant quality system that’s easy to use and adds real value to your business, you can drop us an Email help@brandwoodbiomedical.com or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)

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