Training | Consultancy | Auditing 
+353 1 204 0646 
Hello guest
Your basket is empty

MDSAP Training Program - 1 Day -  Virtual Classroom  

Apr 15 2022 8 Delegates Maximum per training  €499  Price includes training, all training materials, refreshments during the training where applicable.  Need a quote for In-house Training email us today  Introduction: A global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. The Medical Device Single Audit Program allows an MDSAP recognised Auditing Organisation to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.  Who Should Attend? This training is aimed at those with a working knowledge of a QMS from all levels within the organisation with responsibility for designing, implementing and maintaining Quality Systems including (but not limited to): Quality Assurance Quality Control Quality Managers Regulatory Affairs External Auditors Other Departmental Managers Quality Engineers Internal Auditors  Cancellations Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.      

 Course Objectives: • Identify, implement and revise internal procedures and other documents in relation to  MDSAP requirements • Explain all key terms related to MDSAP • Identify all key players, including participating countries, regulatory bodies, and auditing • organizations • Explain Country-specific QMS requirements under the MDSAP • Plan and prepare for an MDSAP audit • Discuss Audit Companion Document • Understand the New Non-conformance Rating System • Explain the Audit Approval / Re-certification Timeframe  Course Summary The 1-day course on MDSAP is highly interactive with many team exercises and discussion. Some of the specific topics covered include the following • Introduction to MDSAP • MDSAP implications • MDSAP and other Certifications • MDSAP Audit Differences basics • Preparing for MDSAP Audits. • Pros and Cons of MDSAP • Compliance and auditing • Three Step Audit Approval System • MDSAP Application • Audit Companion Document • New Non-conformance Rating System • Audit Approval / Re-certification Timeframe  Specific Requirements for Medical Device Registration and Labelling in Brazil – Australia – Canada - Japan Compare to with EU and US medical device regulations  Training aimed at ensuring those requiring with a good working knowledge a QMS and who are/will be involved in managing / maintaining / implementing / auditing the QMS in relation to MDSAP.   

Medical Device Regulations | 25,26,27 Apr 2022 - 2.5 days
IRCA Certified two and a half day course on Medical Device Regulation.
If you are purchasing the course on behalf of a colleague please fill in the details below so we can email them important course material. If there are additional attendees please add their details in the Additional Attendee section at checkout.
Delegate 1: Name of Delegate:
Delegate 1:Personal Email (work email blocks training materials):
Delegate 1: Personal Mobile Number (to directly contact you):
Add Another Delegate(s):
Payment options include:
Bank Transfer
Purchase Order
Credit Card
Our site uses cookies. For more information, see our cookie policy. Accept cookies and close
Reject cookies Manage settings