Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar
Join us for a webinar on October 26 for a discussion of the webinar .
Medical device regulations in the EU are changing and changing fast. If your business is global, you can’t avoid these crucial adjustments.
With one extension already granted, any organization selling devices in the region now need to be ready for the shift by May 2021. There’s little time to spare to get your processes up to par — but WCS can help get you there.
Who Will Benefit
This 180-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel:
- Regulatory compliance personnel
- Quality managers and directors
- Quality engineers
- Risk management specialists
- Regulatory managers
- Design engineering managers
- Supply chain managers focused on procurement and distribution
- Production managers and engineers
- Document control specialists
- Marketing managers
- Clinical managers
- Clinical evaluation specialists
- Export compliance managers
Benefits of Post-Market Surveillance
Review the new EU-MDR 2017/745
- Key compliance dates
- Transition from Re-active to Pro-active
- Data Inputs and Collection Methods
- Risk Management
- Benefit – Risk Determination
- Post-Market Clinical Follow-up (PMCF)
Post Market Activities are a GMP regulatory requirement for the medical device industry in both the US and European Union. These activities provide a valuable system for obtaining data and continuous feedback about a medical device that is on the market. The objective of Post Market Activities is to utilize real-world data in order to maintain a high standard of product quality and ensure patient safety.
Recently, the European Union has revised the regulatory requirements governing medical devices; including the establishment of new expectations and approaches to post-market surveillance. Mandatory compliance to the new European Medical Device Regulation (MDR) is set for 26 May 2020. Due to the regulation changes, medical device manufactures are focused on implementing quality systems to maintain GMP compliance. In order to achieve that goal, it is essential that medical device manufacturers understand and correctly implement the requirements for post-market surveillance.
This course will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches to ensuring compliance.
Why Should You Attend
At the completion of this course, attendees will be able to:
- What are the key elements of a PMS system?
- How should a PMS system function?
- What is the role of risk management in PMS?
- How do I implement data collection and review procedures
- How does a PMS system benefit my company?