Due Diligence – Quality and Compliance Aspects for Medical Devices

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Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly help you avoid that disaster and help you improve your business success.

Mergers and acquisitions are an on-going and important part of the medical device industry. And Due Diligence is a critical part of that process, setting the stage for either success or disaster. Poor due diligence can lead to quality (ex. Recalls) or compliance (ex. Warning letter or Consent Decree) problems years after an acquisition.

In this webinar, we’ll discuss the Quality/Compliance aspects of Due Diligence for Medical Device companies. We’ll learn from real examples what can go wrong in Due Diligence leading to problems later on. Then we’ll discuss how to prepare, conduct, and report a meaningful Due Diligence. We’ll discuss ways to prioritize issues into those that affect the deal and valuation, and those that should be taken care of short and long term post acquisition.

Areas to be Covered:

Due Diligence Expectations and planning
Team requirements
Lessons Learned from Acquisitions
Red Flags of Quality / Compliance Issues
How to categorize / prioritize Issues
Check List for Due Diligence
Risk Management
Preparing Recommendations for M&A
Preparing Action plans for post-acquisition

Who will Benefit:

Due Diligence team members
Quality Engineers
Compliance Specialists
Compliance Managers
Quality Managers
Consultants and Contractors
Business Leaders wishing to develop an M&A program

Susanne Manz

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance