Medical Device Regulatory Affairs Certification

2 865 usd learn more.

Medical device regulatory affairs certification.

Design and develop medical devices to international quality standards ensure smooth submission meet iso 13485 standards satisfy customers and keep ahead of all regulatory developments with our medical devices training courses. Cfpie s regulatory affairs training and certification program was designed by industry experts to offer a comprehensive study of regulatory principals pitfalls and guidelines provided by governmental organizations. The regulatory affairs certificate. Drug and medical device regulation and the jurisdictional scope of the fda.

No one knows better than you what your regulatory learning needs are so who better to build a certificate program that meets them. Medical devices and pharmaceuticals provides route for you to achieve both tracks in an efficient manner. Pharmaceutical drug and biologic and medical device companies today are challenged with a stringent and continually evolving regulatory environment together with changing technologies and global economic considerations. Single certificates raps members.

This global medical device regulatory affairs professional certification program is an online program which guides the student through a global medical device regulations overview. It discusses how iso13485 2003 the iso standard relates to the industry of medical devices details the regulatory ex. The history of u s. The role of regulatory oversight in product design development and manufacturing including quality control scale up good manufacturing practices gmps and quality systems.

It is intended for individuals employed in regulatory agencies industry consultancies and other settings involved with the regulation of healthcare products. We have dynamic course owners around the world allowing delivery of training in many local languages. The program will review the global applications of the medical device industry. Learn more or enroll in our rac gracp certification course here.

Regulatory affairs certification rac is the only post academic professional credential for reg ulatory professionals in the healthcare product sector. This program is designed to help meet the expanding need for regulatory affairs professionals who are able to understand and interpret regulations across the full spectrum. By taking all six core courses and selecting eight electives you have the opportunity to extend your achievement with a dual certificate acquired in a 12 month timeframe.