Seminar Title : 2 Days Training on Medical Device Registration as per Global Standard( April 2020 )
Time : From to
Date : From 2020-04-24 to 2020-04-25
To provide an overview on new MDR against MDD across EU and other countries.
To provide the general legal requirements to bring a medical product to market like India, USA, Europe etc.
To provide sound knowledge and understanding of global regulatory affairs for medical device and to create a thorough understanding of important regulatory concepts.
To learn about QMS as per ISO 13485:2016, process of CE marking and how to implement in industry.
Deliver innovative, breakthrough regulatory strategies for medical device from design and development, Clinical Investigation, Risk Assessment, Technical filing and registration and Supply chain.
Increase focus on building and strengthening relationship with regulatory authorities to provide timely expert input into medical device development, manufacturing and registration
To evaluate Risk Assessments and Mitigations
Post Marketing Surveillance [PMS], PMCF etc.