Overview
Looking to navigate the complex landscape of EU MDR regulations as a contract manufacturing firm? Our Advanced Certificate in EU MDR is designed to equip you with the knowledge and skills needed to ensure compliance and success in the European market. Learn about key requirements, quality management systems, post-market surveillance, and more. Stay ahead of the competition and enhance your credibility with this specialized certification. Join us today and take your contract manufacturing business to the next level. Don't miss out on this opportunity to boost your expertise and stay ahead of the curve in the ever-evolving regulatory environment.
Sign up now and secure your future in the EU market!
Course structure
• Overview of EU Medical Device Regulation (MDR)
• Roles and responsibilities of contract manufacturing firms under EU MDR
• Quality management systems requirements for contract manufacturing firms
• Post-market surveillance and vigilance requirements
• Clinical evaluation and post-market clinical follow-up
• Labeling and packaging requirements
• Unique Device Identification (UDI) requirements
• Audits and inspections by notified bodies
• Changes and variations to manufacturing processes
• Case studies and practical examples in contract manufacturing under EU MDR
Entry requirements
- The program follows an open enrollment policy and does not impose specific entry requirements. All individuals with a genuine interest in the subject matter are encouraged to participate.
Accreditation
The programme is awarded by UK School of Management (UKSM). This program is not intended to replace or serve as an equivalent to obtaining a formal degree or diploma. It should be noted that this course is not accredited by a recognised awarding body or regulated by an authorised institution/ body.Key facts
The Advanced Certificate in EU MDR for Contract Manufacturing Firms is a comprehensive program designed to equip professionals with the knowledge and skills necessary to navigate the complex regulatory landscape of the European Union Medical Device Regulation (EU MDR).Upon completion of this certificate, participants will gain a deep understanding of the EU MDR requirements as they pertain to contract manufacturing firms, enabling them to ensure compliance and maintain market access for their products.
This certificate is highly relevant to professionals working in the medical device industry, particularly those involved in contract manufacturing. With the EU MDR set to replace the Medical Device Directive (MDD) in May 2021, it is crucial for contract manufacturing firms to stay up-to-date on the latest regulatory requirements to avoid costly delays and penalties.
One unique aspect of this program is its focus on contract manufacturing firms specifically, providing targeted training that addresses the unique challenges and considerations faced by these organizations. Participants will learn how to effectively manage relationships with OEMs, navigate subcontractor agreements, and ensure compliance throughout the supply chain.
Overall, the Advanced Certificate in EU MDR for Contract Manufacturing Firms offers a practical and in-depth education that will empower professionals to successfully navigate the EU MDR landscape and maintain compliance in an ever-evolving regulatory environment.
Why this course?
The Advanced Certificate in EU MDR for Contract Manufacturing Firms is crucial in today's market due to the increasing demand for medical devices and the stringent regulations set by the European Union Medical Device Regulation (EU MDR). In the UK, the medical device industry is projected to grow by 8% over the next decade, creating a need for skilled professionals who understand the complexities of EU MDR compliance. Contract manufacturing firms play a vital role in the production of medical devices, and ensuring compliance with EU MDR is essential to maintain market access and meet regulatory requirements. By obtaining an advanced certificate in EU MDR, professionals in contract manufacturing firms can enhance their knowledge and skills in areas such as quality management systems, risk management, and post-market surveillance. With the UK being a key player in the medical device industry, having a workforce that is well-versed in EU MDR regulations is crucial for the success and growth of contract manufacturing firms. Investing in advanced training and certification can help firms stay competitive and navigate the evolving regulatory landscape effectively.Career path
| Career Opportunities |
|---|
| Regulatory Affairs Specialist |
| Quality Assurance Manager |
| Compliance Officer |
| Supply Chain Coordinator |
| Manufacturing Engineer |
| Product Development Manager |