The final text of the Medical Devices Regulation (MDR) has now been approved by the European Parliament and with a likely implementation date in 2020, it is time for industry to learn, prepare and implement the new requirements.
The European regulatory landscape will be changing significantly, with the Regulation set to impact areas such as classification, clinical investigations and risk management.
This course will prepare and equip you with the knowledge and confidence to develop optimal regulatory strategies, ensuring compliance during this period of change.
Through a combination of theory and practical discussion, this course will allow participants will build on their existing regulatory knowledge to develop improved tactics, ensuring speedy market access and effective life-cycle management of their products.
Kath Clarke is a Regulatory Affairs professional with 30 years’ experience in the Medical Device Industry. She started her career in the Medical Device Industry working for Smith & Nephew, during which time she held a variety of Quality Assurance and Regulatory Affairs roles. After 20 years Kath moved to Tissue Science Laboratories, where she held the position of Regulatory Affairs Manager; her responsibilities included CE marking, vigilance reporting, liaison with the Notified Body and product registration in global markets.
Professionals working within the field of regulatory affairs at an operational and strategic level:
• Regulatory Affairs Head/Director/Manager
• Quality Assurance Management
• Product and Marketing Managers
• Strategy Management
• Regulatory Affairs Attorney and other legal counsel requiring a substantial regulatory compliance background