Medical Device Regulatory Compliance Training, Compliance Best Practices and Standards

Medical Device Regulatory Compliance Training

Medical device regulations across the world are diverse. Each phase in the life span of medical device from development to marketing is regulated. Medical device training will focus on these international regulations related to approval and marketing and will help you to develop and implement effective, consistent and reliable quality management systems. Compliance training will also cover topics such as handling medical device recalls, computer system validation, advertising and promotion, process validation, creating compliant SOPs, medical device risk management and more.

Non-compliance with the device regulations will lead to more products recalls, heftier penalties and possible prosecution of manufacturers. The costs of non-compliance can be huge – in terms of monetary losses and reputational damage as well. Medical device compliance training will provide the industry best practices for preventing device recalls and will help you to prepare for regulatory inspection, including how to do follow-up with the regulatory agencies.

Regulatory Challenges for Medical Device Industry

The medical device industry continues to experience rapid growth rates. This success has brought along with it a number of challenges relating to quality, regulatory compliance, technology, innovation, taxation and supply chain management. An effective training is essential to understand these challenges in the development of the new devices. Medical device compliance training will discuss the recent changes to the regulatory environment for the device industry and how these changes will impact the approval of new devices.

Each country has its own detailed regulatory requirements for foreign medical device manufacturers that should be followed. Failure to comply with these rules can result in detention of products at ports of entry, unnecessary expenses involved in paperwork, and a loss of revenue for the importer. The challenges of introducing devices into the particular market are unique, thus highlighting the importance of training in achieving compliance.

The compliance training will be beneficial for the global medical device industry professionals involved in design and development of medical devices including in-vitro diagnostics, conducting and monitoring clinical investigation, performing risk management and post-market surveillance, and handling data and documents for regulatory submission.

ComplianceOnline Medical Device Training Courses

Subjects such as medical device compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. ComplianceOnline offers these training programs in various formats, including: live webinars, training recordings, CDs, in-person seminars and more. These trainings are led by recognized experts and industry veterans with decades of experience in all aspects of medical device including R&D, manufacturing, quality assurance, approval, and commercialization process.