Medical Device Regulatory Affairs Certification

The role of regulatory oversight in product design development and manufacturing including quality control scale up good manufacturing practices gmps and quality systems.

Medical device regulatory affairs certification.

It discusses how iso13485 2003 the iso standard relates to the industry of medical devices details the regulatory ex. This global medical device regulatory affairs professional certification program is an online program which guides the student through a global medical device regulations overview. Learn more or enroll in our rac gracp certification course here. Drug and medical device regulation and the jurisdictional scope of the fda.

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. 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. No one knows better than you what your regulatory learning needs are so who better to build a certificate program that meets them.

2 865 usd learn more. 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. We have dynamic course owners around the world allowing delivery of training in many local languages. Medical devices and pharmaceuticals provides route for you to achieve both tracks in an efficient manner.

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. 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. The program will review the global applications of the medical device industry. 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.

It is intended for individuals employed in regulatory agencies industry consultancies and other settings involved with the regulation of healthcare products. Single certificates raps members. 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.