How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
A session by Mike Baca, President at White Rook Consulting
0 hr 48 min
Ideation & Prototyping
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Advance Exclusive
Webinar
Remote audits
This course will cover remote audits, virtual Inspections, and other alternative tools and methods regulators have implemented, particularly during the Covid 19 pandemic.
0 hr 40 min
Audit
EU MDR
ISO 13485
FDA
Initial QMS Procedures
QMS Refinement & Regulatory Submissions
Product Launch
Post-Market Surveillance
Course
Supply Chain Management under the MDR, Brexit and Swixit
As a result of the MDR, Brexit and Swixit, manufacturers need to be fully aware of how these changes may impact their current and future supply chain Europe.
0 hr 49 min
Initial QMS Procedures
Product Launch
Post-Market Surveillance
Standard (Free)
Webinar
The Ultimate Guide to Training Management for Medical Device Companies
This ultimate guide provides an in-depth look at answers to those common questions and explains everything you need to know to comply with the applicable requirements as well as establish a training management system that promotes total competence of the members of your medical device organization.
Training
ISO 13485
QMS
Initial QMS Procedures
Post-Market Surveillance
Advance Exclusive
eBook
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
When you want to know more about biocompatibility, you go to the experts! Hear Thor Rollins of Nelson Labs discuss this crucial topic about the intersection of risk, biocompatibility, and change management.
Risk Management
Change Management
Initial QMS Procedures
Product Development
QMS Refinement & Regulatory Submissions
Advance Exclusive
Webinar
