Medical Device Single Audit Programme (MDSAP)The Irish Medtech Skillnet in collaboration with Meddev Solutions Limited is delighted to offer a 3 day in-depth interactive training course on Medical Device Single Audit Programme for Medical Device Clients selling into multiple jurisdictions and specifically into Canada where deadline is fast approaching.
The course is designed to enhance the level of requirements and understanding for those actively both developing and engaging in a MDSAP 13485 Programme.
Content includesThe 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
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 attendQuality 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.
The Connacht Hotel, Galway
2-3 April 2019
Radisson Blu, Little Island., Cork
8-9 May 2019