Post market surveillance is an effective tool to handle crisis management and control public health. The lessening credibility of the medical devices by the consumers and regulatory agencies has led to the popularity of post market surveillance. This course will be focusing on the regulatory expectations for post market surveillance and explain the methods of applying the requirements to medical devices. Topics consist of handling complaints, complaint systems inspections surveillancs systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies and fulfilling compliance requirements.
Training Course Details/Schedule
- Definition of Post Market Surveillance
- Terminology: surveillance, complaint, adverse event...
- Lifespan of a medical instrument
- Importance of risk assessment and risk management
- Medical device design and manufacture:
- Relationships with surveillance & complaint handling
- Requirements for approval & post approval studies
- Adverse event & vigilance reporting
- Definition of a medical device report
- GHTF SG2 guidelines
All our courses can be facilitated as Customized In-House Training course.
Course duration is flexible and the contents can be modified to fit any number of days.
As for Open Enrolment Courses, we offer our clients the flexibility to chose the location, date, and time and our team of experts who are spread around the globe will assist in facilitating the course.
The course fee includes facilitation, training materials, 2 coffee breaks, buffet lunch and a Certificate of successful completion of Training.
FREE Consultation and Coaching provided during and after the course.
Yogyakarta, Jakarta, Bandung, Bogor, Cirebon, Solo, Semarang, Surabaya, Malang, Bali, Lombok, Samarinda, Balikpapan, Banjarmasin, Pontianak, Makassar, Medan, Palembang, Lampung, serta Timor Leste, Thailand, Singapore, dan Kuala Lumpur (dengan harga dan minimal kuota yang berbeda).
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