Medical Device Single Audit Programme (MDSAP)

Date: 8th May 2019 -
9th May 2019
Time: 08:30 - 17:00
Duration: 2 Days
Venue: Radisson Blu, Little Island.
Event details

Medical Device Single Audit Programme (MDSAP)

The course is designed to enhance the level of requirements and understanding for those actively both developing and engaging in a MDSAP 13485 Programme.
The MDSAP is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the program.
This course will be highly interactive and will use accelerated learning techniques and therefore use exercises to consolidate learning

Course Overview:
What is MDSAP
How MDSAP Works
How Does MDSAP fit with other Certifications
How an MDSAP Audit Differs
Interactive Session on completing and participating in a Mock MDSAP Audit

Program Objectives: Aim to aid Develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions to promote greater alignment of regulatory approaches and technical requirements To promote consistency, predictability, and transparency of regulatory programs, it does NOT stop the regulators from still auditing the QMS.

Who should attend: Quality assurance professionals, quality engineers, manufacturing engineers, Research and Design Engineers, regulatory professionals, and Internal Auditors. The content will have great value to individuals who are involved in any aspect of implementing or maintaining a QMS.

For all queries on the event, please call the event organiser:
Michelle Reinecke-Quain, Tel: +353 61 431802

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Delegate cancellation policy

Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.

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Per delegate: €350.00
(plus VAT)
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