FDAnews Announces — New Management Report — Using the MDSAP Model to Win International Device Approval

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If devicemakers pass one MDSAP inspection then they will be ready to pursue marketing authorization in five separate countries. The Using the MDSAP Model to Win International Device Approval management report explains what MDSAP auditors will focus on and teaches readers how to build an internal audit program that will get their quality system in state-of-the-art shape for international inspections.

Using the MDSAP Model to Win International Device Approval
**An FDAnews Management Report**
http://info.fdanews.com/using-the-mdsap-model-to-win-international-device-approval-vocus    

75% of device manufacturers conduct internal audits solely “because they have to — because the FDA and ISO regs say so?”

Instead of cringing at the idea of conducting an internal audit, consider implementing the Medical Device Single Audit Program (MDSAP) model. It’s a single audit of the quality management system and satisfies medical device regulatory authorities.

Currently, Australia, Brazil, Canada, Japan and the United States are participating in the program. If devicemakers pass one MDSAP inspection then they will be ready to pursue marketing authorization in five separate countries.

The Using the MDSAP Model to Win International Device Approval management report explains what MDSAP auditors will focus on and teaches readers how to build an internal audit program that will get their quality system in state-of-the-art shape for international inspections.

Readers will learn:

  • How to conduct an audit covering the standards and regulations addressed under the MDSAP model
  • How to identify and understand the requirements as interpreted by the various regulatory authorities
  • How to determine gaps in current documentation
  • How to “score" a current quality system
  • How to improve the predictability of an audit outcome
  • How to report the audit findings using a standard report template
  • Learning the benefits of enrolling in the MDSAP

Order Using the MDSAP Model to Win International Device Approval and get ahead of the game by learning how to handle this new inspection model.

Who Will Benefit:

  • Auditing and compliance officers
  • QA/QC managers and directors
  • Regulatory/compliance staff
  • International development department

FDAnews Management Report Details:
Using the MDSAP Model to Win International Device Approval
Price: $397
http://info.fdanews.com/using-the-mdsap-model-to-win-international-device-approval-vocus

Easy Ways to Order:
Online:     http://info.fdanews.com/using-the-mdsap-model-to-win-international-device-approval-vocus        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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