The United States has the largest market for medical devices worldwide. This is where the FDA and the Food & Drug Administration come into play. They set specific requirements regarding the effectiveness and safety of medical products. The practical training on Market access for medical devices according to FDA regulations teaches you how to bring a medical product to market in the US.
- Discover the requirements for electronic records, software and process validation, medical device reporting, recalls, and Quality System Inspection Technique (QSIT guidance).
- Learn to work according to the Quality System Regulation (21 CFR 820).
- Understand the regulations and guidance for risk management.
About the training Market access for medical devices according to FDA regulations
More and more companies are setting their sights on the United States due to the enormous growth potential for introducing medical devices to the market. To bring a product to market there, it must comply with the requirements of the FDA: the Food & Drug Administration. The training Market access for medical devices according to FDA regulations will guide you through meeting these requirements.
The extensive experience of the instructor with the FDA makes this training highly recommended for anyone seeking a thorough understanding of FDA regulations and practical strategies for compliance. By the end of this training, you will know how to operate according to the Quality System Regulation (21 CFR 820), understand regulations, guidance, and risk management. You'll also learn about the requirements for electronic records, software and process validation, medical device reporting, recalls, and QSIT guidance for FDA.
Program
During the Market Access for Medical Devices According to FDA Regulations training, the following topics will be covered:
United States versus Europe
- Brief historical perspective and recent developments
- FDA versus Notified Bodies
- Collaboration between FDA and Notified Bodies
Market Entry Approval Routes
- Premarket Approval (PMA), 510(K) submission, De Novo route
- Relationship with European directives (MDR and AIMD)
Requirements for the Quality System
- 21CFR 820: Quality System Regulation
- Specific legislation related to Quality System Registration (QSReg): such as Unique Device Identification (UDI), tracking system, corrections, and withdrawals
- Design verification and design validation
- Process qualification and validation
- Software validation and 21CFR 11 (electronic records & signatures)
- Relationship with ISO 9001, ISO 13485, and ISO14971
How FDA audits a quality system?
- The Quality System Inspection Techniques (QSIT)
- Do's and don'ts during an FDA audit
Summary of FDA requirements and main differences/similarities with European requirements.
Contact us for more informationPlace, dates and prices - Open registrations
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Mikrocentrum uses all-inclusive rates. All mentioned rates are exclusive of VAT and include course materials and package costs.
Members of the Mikrocentrum High Tech Platform get a 10% discount.
Discover the possibilities to organize this course incompany
If you want to train several employees in your company, it is more interesting and cheaper to organize a course at your location. Good coordination to your company-specific situation and the deployment of highly experienced teachers who have earned their spurs in practice are essential in this regard. Mikrocentrum is CEDEO accredited and guarantees the best quality.
Our course manager is happy to think along with you!
Are you interested in an internal company trajectory? Our training manager Barend Blom is happy to visit you without obligation.