About this course
Whether you are working toward the registration of your first CE marked product or you are wanting to diversify into the Medical Device supply chain, ISO13485 is the standard required for all regulatory aspects associated with your processes. This webinar takes you through how to plan and execute an implementation project enabling you to walk away understanding exactly what needs to be done and how to successfully implement ISO13485 within your organisation.
NSF MEDICAL DEVICES have Quality Management experts with experience of various Notified bodies and industry best practices so that we can train and educate in the most effective methods to give you confidence of a successful implementation.
Course outline
Without listing all of the processes required from ISO13485 you will learn how to design the specific processes ranging from how to implement a Design control process through to how to plan the information and analysis of data necessary to review product performance and determine regulatory vigilance.
You will learn how to stay on top of the ever changing requirements associated with Standards, Specification and regulatory requirements therefore enabling your processes to be up to date and capable of giving you confidence that your organisation is effective
You will be able to Manage the implementation project, assigning tasks, milestones, activities, resources and outcomes necessary to be able to advise with confidence that anticipated costs, project management monitoring and communicate effectively with either your supply chain and or your management team.
Venue
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England
Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484
www.marriott.co.uk
Tutors
The tutors for this course are as follows:
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