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Computer System Validation - Reduce Costs and Avoid 483s
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs ...
Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and ...
IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety
The Veterinary Drug Approval Process and FDA Regulatory Oversight
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Quality Control Laboratory Compliance - cGMPs and GLPs>
Latin America: Regulatory Compliance Requirements for Life Science Products ...
FDA's New Import Program for 2018 - Strict Precision
Fostering Employee Engagement
Best in Class Wage & Hour Compliance: The Federal Labor Standards Act (FLSA)
A+ PHR/SPHR/PHRca Certification Review Program
Roadmap of California Medical Leaves - Ultimate Guide to PDL, FMLA, FEHA, SDI ...
Employment Laws for HR Professionals, Managers and Supervisors Certificate Prog...
Managing Your FDA Inspection: Before, During and After
21 CFR Part 820 Quality System Regulation and FDA cGMP Requirements for Med ...
Data Integrity and Good Documentation Practices
Principles and Application of Hazard Analysis Critical Control Point (HACCP)
FDA Regulations for Dietary Supplements Manufacturers (21 CFR Part 111, GMP ...
Implementing the New Australian Standard for Product Recall
REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tis ...
Business Continuity Auditing Plans Using ISO 22301
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› Medical Device compliance Training
Medical Device Regulatory Compliance Training, Compliance Best Practices and Standards
Medical device regulations based webinars, in-person seminars, standards and best practices. Learn from renowned experts about FDA regulations for Medical Devices and compliance requirements - ISO 13485, ISO 14971 standards, EU MDD, Quality System Regulations (QSR), Medical Device Reporting (MDR), Computer system validation, Device history records (DHR) and, Packaging and labeling regulations, etc.

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.
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