Medical Device Regulatory Affairs Certification

The regulatory affairs certificate. If you have already successfully completed a regulatory affairs certificate in medical devices you can complete the two remaining core courses of the dual certificate not taken as part of your original certificate program and three additional electives to receive recognition of satisfactory achievement of the dual certificate. Regulatory affairs certification rac is the only post academic professional credential for reg ulatory professionals in the healthcare product sector.

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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.

Medical device regulatory affairs certification.

It discusses how iso13485 2003 the iso standard relates to the industry of medical devices details the regulatory ex. The role of regulatory oversight in product design development and manufacturing including quality control scale up good manufacturing practices gmps and quality systems. Medical devices and pharmaceuticals provides route for you to achieve both tracks in an efficient manner. Drug and medical device regulation and the jurisdictional scope of the fda.

The graduate certificate in medical devices regulatory affairs provides an in depth knowledge of the regulations and standards that apply to the development of medical devices including those products not specifically regulated by federal law. 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. This global medical device regulatory affairs professional certification program is an online program which guides the student through a global medical device regulations overview. Single certificates raps members.

No one knows better than you what your regulatory learning needs are so who better to build a certificate program that meets them. First explore the certificate program that suits you best. The program will review the global applications of the medical device industry. 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.

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. 2 865 usd learn more. It is intended for individuals employed in regulatory agencies industry consultancies and other settings involved with the regulation of healthcare products. 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.

The history of u s. We have dynamic course owners around the world allowing delivery of training in many local languages. Learn more or enroll in our rac gracp certification course here.

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