Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Medidee in brief – www.medidee.comPre – <strong>Market</strong> support :• Regulatory pathway development• Clinical evaluation m<strong>an</strong>agement• Design <strong>an</strong>d review of Technical Files• Support of Product- <strong>an</strong>d Process- V&V• Implementation of QMS• Preparing for third party audits <strong>an</strong>dinspections• Supplier qualification• Software validation• R<strong>is</strong>k <strong>an</strong>alys<strong>is</strong> at the product or systemlevelStrategic M<strong>an</strong>agement support :• Regulatory troubleshooting• R<strong>is</strong>k <strong>an</strong>alys<strong>is</strong> at the org<strong>an</strong>ization level• Regulatory due diligence / M&A• Coaching of startups• Interim M<strong>an</strong>agement• Training of executives <strong>an</strong>d staff<strong>Post</strong>- <strong>Market</strong> support :• EU Representative services• Periodic PMS & regulatory intelligenceresearch according defined protocols
Change language